← Product Code [BTT](/productcode/BTT) · K262268 # Optiflow Oxygen Kit (AA484J) (K262268) _Fisher and Paykel Healthcare Limited · BTT · Aug 27, 2026 · Anesthesiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K262268 ## Device Facts - **Applicant:** Fisher and Paykel Healthcare Limited - **Product Code:** [BTT](/productcode/BTT.md) - **Decision Date:** Aug 27, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 868.5450 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use This product delivers respiratory gases to adult patients. It is intended for use with an F&P 820 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup. This product is indicated for the delivery of nasal high flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical procedure or surgical room. Qualitative carbon dioxide sampling can be used at nasal interface flow rates from 5 to 50 L/min. This product can be used for preoxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist. This product is not intended for apneic ventilation. ## Device Story AA484J Optiflow Oxygen Kit is a multi-patient use breathing set; delivers humidified respiratory gases to adult patients. Components include dry line, humidification chamber, inspiratory limb, tubing clips, date-change stickers. Used with F&P 820 humidifier; flow range 5-70 L/min. Enables nasal high flow (NHF) delivery; supports qualitative CO2 sampling (5-50 L/min) and preoxygenation/supplemental oxygenation during intubation. Operated by qualified healthcare professionals in hospital settings (OR/procedure rooms). Requires hydrophobic filter for multi-patient use; maximum 24-hour use after setup; reprocessed between patients (max 30 cycles). Output is humidified gas stream; assists clinicians in airway management and oxygenation; benefits patients by providing respiratory support during procedures. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing and biocompatibility evaluation per ISO 10993-1:2020 and ISO 18562-1:2024. ## Technological Characteristics Multi-patient use breathing set; non-sterile. Components: dry line, humidification chamber, inspiratory limb. Flow range: 5-70 L/min. Compatible with F&P 820 humidifier. Biocompatibility per ISO 10993-1 and ISO 18562-1. Reusable (max 30 cycles). ## Regulatory Identification A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device. ## Predicate Devices - F&P Optiflow Oxygen Kit (AA403) ([K211096](/device/K211096.md)) ## Reference Devices - F&P Optiflow Oxygen Kit Valve Coated (AA404) ([K234053](/device/K234053.md)) - AA451J Optiflow Oxygen Kit ([K233821](/device/K233821.md)) - MR325 F&P 820 Chamber Manual Fill 500ml ([K223684](/device/K223684.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 27, 2026 Fisher and Paykel Healthcare Limited Amelia Rosario Regulatory Affairs Associate 15 Maurice Paykel Pl., E. Tamaki Auckland, 2013 New Zealand Re: K262268 Trade/Device Name: Optiflow Oxygen Kit (AA484J) Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: July 28, 2026 Received: July 29, 2026 Dear Amelia Rosario: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} K262268 - Amelia Rosario Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K262268 - Amelia Rosario Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ethan L. Nyberg -S Ethan Nyberg, Ph.D. Assitant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K262268 ? Please provide the device trade name(s). ? Optiflow Oxygen Kit (AA484J) Please provide your Indications for Use below. ? This product delivers respiratory gases to adult patients. It is intended for use with an F&P 820 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup. This product is indicated for the delivery of nasal high flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical procedure or surgical room. Qualitative carbon dioxide sampling can be used at nasal interface flow rates from 5 to 50 L/min. This product can be used for preoxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist. This product is not intended for apneic ventilation. Please select the types of uses (select one or both, as applicable). ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) Please select the age group(s) for which the device(s) is to be used. ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) ? ? {4} AA484J Optiflow Oxygen Kit # 510(k) Summary As Required by 21 CFR 807.92 ## I. SUBMITTER | Company Name and Address | Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place East Tamaki Auckland 2013, New Zealand Telephone: +64 9 574 0100 | | --- | --- | | Prepared and Submitted by | Amelia Rosario Regulatory Affairs Associate | | --- | --- | | Contact Person | Reena Daken Regulatory Affairs Manager – North America Telephone: +64 9 574 0100 Email: Reena.Daken@fphcare.co.nz | | --- | --- | | Date Prepared | 18 June 2026 | | --- | --- | ## II. DEVICE | Name of Device | AA484J Optiflow Oxygen Kit | | --- | --- | | Common/Usual Name | Respiratory Gas Humidifier | | Classification Name | 21 CFR 868.5450 | | Regulatory Class | II | | Product Code | BTT | ## III. PREDICATE DEVICE Predicate Device: F&P Optiflow Oxygen Kit (AA403), K211096. Reference device 1: F&P Optiflow Oxygen Kit Valve Coated (AA404), K234053 Reference device 2: AA451J Optiflow Oxygen Kit, K233821 Reference device 3: MR325 F&P 820 Chamber Manual Fill 500ml, K223684 Page 1 of 5 {5} AA484J Optiflow Oxygen Kit #### IV. DEVICE DESCRIPTION The AA484J Optiflow Oxygen Kit is a multiple-patient use breathing set. The kit consists of a dry line, humidification chamber, inspiratory limb, tubing clips and date-change stickers. The AA484J delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDA-cleared hydrophobic filter, the AA484J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup. When used with the appropriate accessories, the AA484J enables the delivery of nasal high flow (NHF) to adult patients by appropriately qualified healthcare professionals who perform anaesthesia care and airway management. The AA484J is prescription only and provided in a non-sterile state. #### V. INDICATIONS FOR USE This product delivers respiratory gases to adult patients. It is intended for use with an F&P 820 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup. This product is indicated for the delivery of nasal high flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical procedure or surgical room. Qualitative carbon dioxide sampling can be used at nasal interface flow rates from 5 to 50 L/min. This product can be used for preoxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist. This product is not intended for apneic ventilation. Page 2 of 5 {6} AA484J Optiflow Oxygen Kit ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Design/technological characteristics | Subject device AA484J Optiflow Oxygen Kit | Predicate device F&P Optiflow Oxygen Kit (AA403) (K211096) | Comments | | --- | --- | --- | --- | | **Indications for use and intended use** | | | | | Indications for Use | This product delivers respiratory gases to adult patients. It is intended for use with an F&P 820 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup. This product is indicated for the delivery of nasal high flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical procedure or surgical room. Qualitative carbon dioxide sampling can be used at nasal interface flow rates from 5 to 50 L/min. This product can be used for preoxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist. This product is not intended for apneic ventilation. | This product delivers respiratory gases to adult patients. It is intended for use with an MR810 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup. This product is indicated for the delivery of Nasal High Flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical procedure or surgical room. Qualitative carbon dioxide sampling can be used at nasal interface flow rates from 5 to 50 L/min. This product can be used for preoxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist. This product is not intended for apneic ventilation. | Identical | | Availability | Prescription use (Part 21 CFR 801 Subpart D) | Prescription use (Part 21 CFR 801 Subpart D) | Identical | | Patient Population | Adult patients | Adult patients | Identical | Page 3 of 5 {7} AA484J Optiflow Oxygen Kit | Design/technological characteristics | Subject device AA484J Optiflow Oxygen Kit | Predicate device F&P Optiflow Oxygen Kit (AA403) (K211096) | Comments | | --- | --- | --- | --- | | Intended Use Environment | Hospital Environment | Hospital Environment | Identical | | **Operation and safety features** | | | | | Ambient Operating Temperature | 18 to 26 °C (64.4 to 78.8°F) | 18 to 26 °C (64.4 to 78.8°F) | Identical | | System Specifications | **Flow Range**: 5 to 70 L/min | **Flow Range**: 5 to 70 L/min | Identical | | Shelf Life | 2 years | 2 years | Identical | | Storage Temperature | 10 °C to +50 °C (14 to 122 °F) | -10 °C to +50 °C (14 to 122 °F) | Identical | | Sterility | Device not provided sterile. | Device not provided sterile. | Identical | | Reusability | Multi-patient use | Multi-patient use | Identical | | Disposal | Dispose of product safely in accordance with standard hospital procedure. | Dispose of product safely in accordance with standard hospital procedure. | Identical | | **Components and Materials** | | | | | Inspiratory Tube | Included | Included | Identical | | Water/Humidification Chamber | Included | Included | Similar | | Clip | Included | Included | Identical | | Dryline | Included | Included | Similar | Page 4 of 5 {8} Optiflow Switch+ Filtered Nasal Interface with CO₂ Sampling ## VII. PERFORMANCE DATA ### Summary of Biocompatibility Testing Performance testing was completed using the same FDA recognized consensus standards as the predicate device and confirms the subject device does not raise new questions of safety and effectiveness. The testing demonstrates substantial equivalence of the subject device to the predicate device. The subject device has been tested to the applicable requirements of the following standards: - ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process - ISO 18562-1:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process ## VIII. CONCLUSION The subject device is substantially equivalent to the predicate based on patient population, intended uses, comparison of the technological characteristics, and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices. Page 5 of 5 --- **Source:** [https://fda-staging.innolitics.com/device/K262268](https://fda-staging.innolitics.com/device/K262268) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com