RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

K251826 · Smith & Nephew Medical, Ltd. · OMP · Sep 11, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K251826
• Device Name: RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
• Applicant: Smith & Nephew Medical, Ltd.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Sep 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is intended to be used in conjunction with Smith+Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS systems. The Smith+Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types for RENASYS WOUND+ Dressing include: - Chronic - Acute - Traumatic - Sub-Acute and dehisced wounds - Ulcers (such as pressure or diabetic) - Partial-thickness burns - Flaps - Grafts RENASYS WOUND+ Dressing without filler can be used on the following additional wound type: - Closed surgical incisions The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology in Small, Medium, and Large sizes is intended to be used with Smith+Nephew RENASYS TOUCH, RENASYS GO, and RENASYS EDGE NPWT systems.

Device Story

Dressing kit accessory for RENASYS NPWT systems (TOUCH, GO, EDGE); facilitates negative pressure wound therapy by creating closed environment over wound; enables evacuation of exudate, irrigation, and infectious materials into collection canister. Used in clinical settings by healthcare providers; kit includes AIRLOCK technology film and retention strips; can be used with or without wound filler (foam/gauze). Benefits patient by managing wound environment to promote healing. Device performance verified via simulated wound models and human factors validation.

Clinical Evidence

No clinical performance data was necessary. Substantial equivalence supported by non-clinical bench testing (simulated wound models) and human factors validation.

Technological Characteristics

Dressing kit with AIRLOCK technology film and retention strips. Functions as interface for negative pressure wound therapy systems. Compatible with RENASYS TOUCH, GO, and EDGE pumps. Materials and biological evaluation rely on predicate data.

Indications for Use

Indicated for patients requiring negative pressure wound therapy for management of chronic, acute, traumatic, sub-acute, dehisced wounds, ulcers (pressure/diabetic), partial-thickness burns, flaps, grafts, and closed surgical incisions.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• RENASYS Foam Wound Dressing Kits with AIRLOCK Technology and Soft Port (K243576)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

September 11, 2025

Smith & Nephew Medical Ltd
Sam Greenhalgh
Regulatory Affairs Director
101 Hessle Road
Hull, East Riding of Yorkshire HU3 2BN
United Kingdom

Re: K251826
Trade/Device Name: RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered suction pump
Regulatory Class: Class II
Product Code: OMP
Dated: June 13, 2025
Received: June 13, 2025

Dear Sam Greenhalgh:

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}

K251826 - Sam Greenhalgh
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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}

K251826 - Sam Greenhalgh
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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Yu-chieh Chiu -S

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)
K251826

Device Name
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

Indications for Use (Describe)
The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is intended to be used in conjunction with Smith+Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS systems. The Smith+Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types for RENASYS WOUND+ Dressing include:
- Chronic
- Acute
- Traumatic
- Sub-Acute and dehisced wounds
- Ulcers (such as pressure or diabetic)
- Partial-thickness burns
- Flaps
- Grafts

RENASYS WOUND+ Dressing without filler can be used on the following additional wound type:
- Closed surgical incisions

The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology in Small, Medium, and Large sizes is intended to be used with Smith+Nephew RENASYS TOUCH, RENASYS GO, and RENASYS EDGE NPWT systems.

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
[e-mail]

"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 [phone]

{4}

K251826

# 510(k) Summary (K251826)

| 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 | [phone] |
| Contact Person | Sam Greenhalgh |
| Date Prepared | 11th September 2025 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name | RENASYS™ WOUND+ Dressing Kits with AIRLOCK™ Technology |
| Common Name | RENASYS WOUND+ Dressing Kits |
| Classification Name | Negative Pressure Wound Therapy Powered Suction Pump |
| 21 CFR 807.92 (a)(3): Legally marketed device to which equivalence is claimed | |
| Predicate 510(k) Number | K243576 |
| Predicate Device Name | RENASYS Foam Wound Dressing Kits with AIRLOCK Technology and Soft Port |
| 21 CFR 807.92 (a)(4): Device Description | |
| RENASYS WOUND+ Dressing kits with AIRLOCK Technology can be used without a wound filler, with foam or with gauze wound filler. The kits are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems. RENASYS Negative Pressure Wound Therapy allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. | |
| 21 CFR 807.92 (a)(5): Intended Use / Indications for use | |
| The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is intended to be used in conjunction with Smith+Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS systems. The Smith+Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types for RENASYS WOUND+ Dressing include: • Chronic • Ulcers (such as pressure or diabetic) • Acute • Partial-thickness burns • Traumatic • Flaps • Sub-Acute and dehisced wounds • Grafts RENASYS WOUND+ Dressing without filler can be used on the following additional wound type: • Closed surgical incisions The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology in Small, Medium, and Large sizes is intended to be used with Smith+Nephew RENASYS TOUCH, RENASYS GO, and RENASYS EDGE NPWT systems. | |

Page 1 of 2

{5}

RENASYS™ WOUND+ Dressing Kits with AIRLOCK™ Technology

Traditional 510(k) Premarket Notification - K251826

| 21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices | | |
| --- | --- | --- |
| | | |
| Characteristics | Subject Device | Predicate Device |
| Intended Use | Same as Predicate | Intended to create a closed environment over a wound to allow negative pressure wound therapy to evacuate exudate from the wound into a collection canister |
| Indications for Use | Same as Predicate with the addition of Closed Surgical Incisions | Chronic, Acute, Traumatic, Sub-Acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partial thickness burns, Flaps and Grafts |
| Kit Components | Same as predicate except the removal of the wound filler | RENASYS Film with AIRLOCK Technology, Retention Strips, Wound Filler, User Manual |
| | | |
| 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 by handling wound fluids and 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 • Human Factors validation study demonstrated safe use by all test subjects The following non-clinical testing was not complete as the data generated for the predicate is applicable: • 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 device (K243576) and there are no new questions of safety or effectiveness. | | |

Page 2 of 2