RENASYS DYNAFLOW Kit (66807741)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 11, 2026 Smith & Nephew Medical, Ltd. Eve Lester Senior Regulatory Affairs Specialist 101 Hessle Rd. Hull, East Riding of Yorkshire HU3 2BN United Kingdom Re: K261338 Trade/Device Name: RENASYS DYNAFLOW Kit (66807741) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 12, 2026 Received: August 12, 2026 Dear Eve Lester: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261338 - Eve Lester 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. {2} K261338 - Eve Lester Page 3 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). Sincerely, MUSTAFA A. MAZHER -S For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K261338 Device Name RENASYS DYNAFLOW Kit (66807741) Indications for Use (Describe) The RENASYS DYNAFLOW system is intended to be used in conjunction with Smith + Nephew RENASYS EDGE and RENASYS TOUCH NPWT for the application of negative pressure wound therapy to the wound to promote wound management by the delivery of saline to the wound bed and removal of fluids (including saline, irrigation fluids, body fluids, wound exudates and infectious material). For patients who would benefit from vacuum assisted drainage and controlled delivery of saline over the wound bed. The RENASYS DYNAFLOW device is intended for use in the clinical setting by clinicians. Appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure and diabetic), partial-thickness burns, flaps, and grafts. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} RENASYS DYNAFLOW Kit Traditional 510(k) Premarket Notification K261338 ## **510K Summary** | 21 CFR 807.92 (a)(1): Submitter's Information | | | --- | --- | | Applicant | Smith & Nephew Medical Ltd | | Address | 101 Hessle Road, Hull, HU3 2BN, United Kingdom | | Telephone Number | +447740531714 | | Contact Person | Eve Lester | | Date Prepared | 9^{th} September 2026 | | 21 CFR 807.92 (a)(2): Device Information | | | Device Name | RENASYS DYNAFLOW Kit (66807741); | | Common Name | RENASYS DYNAFLOW Kit | | Classification Name | Negative Pressure Wound Therapy Powered Suction Pump | | 21 CFR 807.92 (a)(3): Legally marketed device to which equivalence is claimed | | | 510(k) Number | K161418 (Primary Predicate) K203316 | | Device Name | Cardinal Health NPWT Irrigation Tubing Set (Primary Predicate) V.A.C Ulta Negative Pressure Wound Therapy System with Veraflo Therapy | | 21 CFR 807.92 (a)(4): Device Description | | | The subject device is sterile and single-use device, intended to deliver saline to the wound bed under negative pressure. The subject device is intended to be used in conjunction with the existing RENASYS Negative Pressure wound therapy system, and is intended to be compatible with the RENASYS TOUCH, RENASYS EDGE and RENASYS Foam Dressing Kits. | | | The device can be used with the below optional RENASYS DYNAFLOW stand intended to hold the RENASYS DYNAFLOW device, saline container and the applicable RENASYS Negative Pressure Wound Therapy (NPWT) pump. | | | - RENASYS DYNAFLOW Stand (66807743 (RENASYS EDGE)); - RENASYS DYNAFLOW Stand (66807742 (RENASYS TOUCH)) | | | 21 CFR 807.92 (a)(5): Intended Use/Indications for use | | Page 1 of 4 {5} RENASYS◊ DYNAFLOW Kit Traditional 510(k) Premarket Notification K261338 The RENASYS DYNAFLOW system is intended to be used in conjunction with Smith + Nephew RENASYS EDGE and RENASYS TOUCH NPWT for the application of negative pressure wound therapy to the wound as the device to promote wound management by the delivery of saline to the wound bed and removal of fluids (including saline, irrigation fluids, body fluids, wound exudates and infectious material). For patients who would benefit from vacuum assisted drainage and controlled delivery of saline over the wound bed. The RENASYS DYNAFLOW device is intended for use in the clinical setting by clinicians. Appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure and diabetic), partial-thickness burns, flaps, and grafts. 21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices The subject device (RENASYS DYNAFLOW) is equivalent to the predicate devices when used as part of a NPWT system. The subject device and the predicate devices have equivalent intended uses (Dwell for K203316 and Intermittent/continuous for K161418), all devices are intended for; - Removal of fluid from the wound to facilitate a moist wound healing environment - Delivery of NPWT to provide an environment to allow for wound closure | Characteristics | Subject Device | V.A.C. Ulta with Veraflo therapy K203316 | Cardinal Health NPWT Irrigation Tubing Set and Delivery Set K161418 (Primary Predicate) | | --- | --- | --- | --- | | Indications for Use | Equivalent. Differences do not raise new or substantially different questions of safety and efficacy. | | | | | The RENASYS DYNAFLOW system is intended to be used in conjunction with Smith + Nephew RENASYS EDGE and RENASYS TOUCH NPWT for the application of negative pressure wound therapy to the wound to promote wound management by the delivery of saline to the wound bed and removal of fluids (including saline, irrigation fluids, body fluids, wound exudates and infectious material). | The V.A.C.® Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy (V.A.C.® Therapy) with an instillation option (Veraflo™ Therapy). • V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed | The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SYED, PRO Family and PRO HC devices, which are indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT | Page 2 of 4 {6} RENASYS◊ DYNAFLOW Kit Traditional 510(k) Premarket Notification K261338 | | For patients who would benefit from vacuum assisted drainage and controlled delivery of saline over the wound bed. The RENASYS DYNAFLOW device is intended for use in the clinical setting by clinicians. Appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure and diabetic), partial-thickness burns, flaps, and grafts. | primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. • Veraflo™ Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The V.A.C.® Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts. • V.A.C.® Therapy in the absence of instillation may also be used for: o The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within | system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting. | | --- | --- | --- | --- | Page 3 of 4 {7} RENASYS◊ DYNAFLOW Kit Traditional 510(k) Premarket Notification K261338 | | | the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater. o The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. | | | --- | --- | --- | --- | | 21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/relied on in the submission to determine substantial equivalence | | --- | | Verification and validation activities conducted demonstrate the subject device continues to perform as intended within the NPWT system by handling wound fluids and irrigation fluids while delivering negative pressure wound therapy. The principal test methods used to demonstrate performance were simulated wound model tests. Non-clinical performance testing was conducted for the determination of substantial equivalence: • Simulated wound model testing demonstrated the subject device performed as intended, including maintaining the delivery of NPWT and management of exudate and irrigation fluids • Biological Evaluation | | 21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/references/relied on in this submission to determine substantial equivalence | | No Clinical performance data was necessary. | | 21CFR 807.92 (b) (3): Conclusions drawn from the nonclinical tests | | Based on the non-clinical performance testing provided in this submission, the subject device is substantially equivalent to the legally marketed predicate devices and there are no new questions of safety or effectiveness. | Page 4 of 4