NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)

{0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION September 18, 2026 ICU Medical Luis Ramirez Manager, Regulatory Affairs 600 N. Field Dr. Lake Forest, Illinois 60045 Re: K262532 Trade/Device Name: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LGZ Dated: July 22, 2026 Received: July 22, 2026 Dear Luis Ramirez: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262532 - Luis Ramirez Page 2 (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-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). {2} K262532 - Luis Ramirez Page 3 Sincerely, Jake K. Lindstrom -S Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology 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. K262532 Please provide the device trade name(s). NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) Please provide your Indications for Use below. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for the administration of warmed irrigating fluids. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for use with NORMOFLO™ Irrigation Fluid Warmers only. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for use with adult patients. 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} NORMOFLO™ Irrigation Fluid Warming Sets and Accessories Traditional 510(k) 510(k) Summary icumedical human connections ### K262532 510(k) Summary A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 880.5725 for the NORMOFLO™ Irrigation Fluid Warming Sets and Accessories is provided below. | **Submitter Information** | | | --- | --- | | Name | ICU Medical, Inc | | Address | 600 N Field Dr Lake Forest, IL, 60045 | | Phone Number | 224-706-2419 | | Fax Number | N/A | | Establishment Registration Number | 3013319212 | | Name of Contact Person | Luis Ramirez | | Date Prepared | July 22, 2026 | | **Name of Device** | | | Trade or Proprietary Name | NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | | Common or Usual Name | Warmer, Thermal, Infusion Fluid | | Classification | II | | Regulation Number | 21 CFR 880.5725 | | Review Panel | General Hospital | | Product Code | LGZ | | **Predicate Device (Legally marketed device to which equivalence is claimed)** | | | Trade or Proprietary Name | NORMOFLO Irrigation Warming Sets (K072080) | | Common or Usual Name | Warmer, Thermal, Infusion Fluid | | Classification | II | | Regulation Number | 21 CFR 880.5725 | | Review Panel | General Hospital | | Product Code | LGZ | | **Reason for 510(k) submission** | This submission establishes an updated regulatory baseline, including updates made in response to field actions and updating the design to meet the latest standards. | | **Device Description** | The NORMOFLO™ Irrigation Fluid Warming Sets are used for the administration of warmed irrigation fluids, which are delivered to the patient under gravity flow or pressurized flow. The warming of infusates is achieved through a sealed heat exchanger. The NORMOFLO™ Irrigation Fluid Warming Sets are used in combination with NORMOFLO Irrigation Fluid Warmers as a system. | | **Intended Use/Indications for Use** | The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for the administration of warmed irrigating fluids. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for use with NORMOFLO™ Irrigation Fluid Warmers only. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories is intended for use with adult patients. | Page 1 of 5 {5} NORMOFLO™ Irrigation Fluid Warming Sets and Accessories Traditional 510(k) 510(k) Summary **icumedical** human connections # **Summary of the technological characteristics of the device compared to the predicate device** | Feature | Subject of Submission: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories | Predicate Device: NORMOFLO® Irrigation Warming Set K072080 | Comparison | Impact on Safety and Effectiveness | | --- | --- | --- | --- | --- | | Product Code | LGZ | LGZ | Same | No impact on safety and effectiveness. | | Indications for Use Statement | The NORMOFLO™ Irrigation Fluid Warming Sets and accessories are intended for the administration of warmed irrigating fluids. The NORMOFLO™ Irrigation Fluid Warming Sets and accessories are intended for use with NORMOFLO™ Irrigation Fluid Warmers only. The NORMOFLO™ Irrigation Fluid Warming Sets and accessories is intended for use with adult patients. | The Level 1® Fluid Warmer NORMOFLO® Irrigation Warming Set (Disposable Set) is a disposable irrigating fluid administration set, designed for use by trained medical professionals, for warming irrigating fluids. The disposable set is intended for use with the Level 1® H-1100 series NORMOFLO® Irrigation Fluid Warmers only | Similar | No impact on safety and effectiveness. Updated wording clarifying patient population. No change in clinical use of the device. | | Intended Users and Use Environment | The NORMOFLO™ Irrigation Fluid Warming Sets and accessories are intended for use by trained healthcare professionals within healthcare facilities. | The Level 1® Fluid Warmer NORMOFLO® Irrigation Warming Sets are designed for use by trained medical professionals | Similar | No impact on safety and effectiveness. Although the use environment was not specified for the predicate device, this device has always been used in healthcare facilities only. | | Contraindications | None | None | Same | No impact on safety and effectiveness. | | Fluid Warmer Compatibility | Compatible with NORMOFLO Fluid Warmer only | Compatible with NORMOFLO Fluid Warmer only | Same | No impact on safety and effectiveness. | | Fundamental technology | Supply Line Heat Exchanger Vent Filter Spare Bag Spike Patient Line | Supply Line Heat Exchanger Vent Filter Spare Bag Spike Patient Line | Same | No impact on safety and effectiveness. | Page 2 of 5 {6} NORMOFLO™ Irrigation Fluid Warming Sets and Accessories Traditional 510(k) 510(k) Summary icumedical human connections | Feature | Subject of Submission: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories | Predicate Device: NORMOFLO® Irrigation Warming Set K072080 | Comparison | Impact on Safety and Effectiveness | | --- | --- | --- | --- | --- | | Primary materials of construction | ABS PVC Aluminum Polypropylene LDPE Silicone Acrylic | ABS PVC Aluminum Polypropylene LDPE Silicone Acrylic | Similar | No impact on safety and effectiveness. Subject device has been fully characterized to identify all materials of construction. Device has been subject to comprehensive biocompatibility evaluation per ISO 10993-1. | | Primary plasticizers used in the fluid path | TOTM | DEHP | Different | No impact on safety and effectiveness. TOTM has been selected as a suitable replacement for DEHP in the subject device. TOTM has been evaluated through biocompatibility evaluation per ISO 10993-1 in subject device. | | Heat Exchanger Coating | Parylene C coating | No coating | Different | No impact on safety and effectiveness. Similar heat exchanger design. The parylene C coating has been verified through biocompatibility and coating adhesion testing. | | Sterility | Sterile barrier system | Sterile fluid path | Similar | No impact on safety and effectiveness. Sterile barrier system involves more stringent testing to ensure protection of the entire device sterility until point of use per ISO 11607-1 requirements. | | Sterilization method | EO | EO | Same | No impact on safety and effectiveness. | | SAL | 10⁻⁶ | 10⁻⁶ | Same | No impact on safety and effectiveness. | | Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same | No impact on safety and effectiveness. | | Shelf-Life | 2 years | 4 years | Different | No impact on safety and effectiveness. Packaging and device performance have been evaluated to the end of the shelf life. | | Single Use/Reusable | Single Use | Single Use | Same | No impact on safety and effectiveness. | | Prescription use/Over-the-Counter use | Prescription use | Prescription use | Same | No impact on safety and effectiveness. | Page 3 of 5 {7} NORMOFLO™ Irrigation Fluid Warming Sets and Accessories Traditional 510(k) 510(k) Summary icumedical human connections | Feature | Subject of Submission: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories | | | Predicate Device: NORMOFLO® Irrigation Warming Set K072080 | Comparison | Impact on Safety and Effectiveness | | --- | --- | --- | --- | --- | --- | --- | | Patient Line Length | 274.3 cm | | | Not reported | N/A | No impact on safety and effectiveness. Changes in the subject device required new performance characterization. IFU discloses patient line length. | | Priming Volume | SKU | Component | Priming Volume | Not reported | N/A | No impact on safety and effectiveness. Changes in the subject device required new performance characterization. IFU discloses priming value and provides instructions to properly prime the fluid warming sets. | | | IR-601 | Supply Line+Heat Exchanger+Gas Vent | 188 mL | | | | | | | Gas Vent | 40 mL | | | | | | | Patient Line | 96 mL | | | | | | | Spare Spike | 23 mL | | | | | | IR-501 | Supply Line+Heat Exchanger+Gas Vent | 132 mL | | | | | | | Patient Line | 93 mL | | | | | | | Spare Spike | 23 mL | | | | Page 4 of 5 {8} *NORMOFLO™ Irrigation Fluid Warming Sets and Accessories* Traditional 510(k) 510(k) Summary **icumedical** human connections ### Summary of Non-Clinical Testing The performance testing activities on the NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are comprehensive and include design input verification activities, and validation of user need and risk controls. The testing was conducted to demonstrate that the subject device is adequately safe and effective for its intended users, intended uses, and use environments. Non-clinical testing includes different test types such as functional testing, analysis, performance testing, standards compliance testing, sterility, stability (shelf life), biological evaluation, packaging, and labeling. ### Clinical Information Clinical evaluation is not required for this submission to support substantial equivalence. ### Conclusion The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories meet the intended use and functional claims described in the product labeling. The technological characteristics—including functional specifications, components, design, sterilization method, shelf-life, and materials of construction—are substantially equivalent to those of the predicate device. Performance testing demonstrates that the subject device meets all predefined acceptance criteria. The modifications described do not alter the intended use or fundamental scientific technology and do not raise new or different questions of safety or effectiveness. Based on this information, the NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are substantially equivalent to the currently marketed predicate device. ---Page 5 of 5