# Smith & Nephew Medical Limited

- Location (FDA's records): Hull, GB
- FDA decisions: 33 (1989–2026): 33 510(k) clearances
- Names in FDA's records: Smith & Nephew Medical Limited (19); Smith & Nephew Medical, Ltd. (10); Smith & Nephew Medical (3); Smith Nephew Medical Limited (1)
- Product codes: OMP (23), FRO (5), LYY (3), FQH (1), KGN (1)
- 510(k) review time since 2016: median 152 days, against 214 for FDA's reviews in the same codes and years (16 of 30 faster)
- Predicates its devices cite: 36 (17 its own); citations of its devices by later devices: 25 (17 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc.: 11 (https://510kreport.com/company/smith-nephew)
- Oclassen Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/oclassen-pharmaceuticals)
- Perstorp AB C/O Robert Joel Slomoff: 1 (https://510kreport.com/company/perstorp-ab-c-o-robert-joel-slomoff)
- Molnlycke Health Care Us, LLC: 1 (https://510kreport.com/company/molnlycke-health-care-us)
- Sterling Drug, Inc.: 1 (https://510kreport.com/company/sterling-drug)
- Medela AG: 1 (https://510kreport.com/company/medela)
- Molnlycke Health Care, Inc.: 1 (https://510kreport.com/company/molnlycke-health-care)
- Cardinalhealth: 1 (https://510kreport.com/company/cardinalhealth)

## Firms that cite its devices most
- Genadyne Biotechnologies, Inc.: 2 (https://510kreport.com/company/genadyne-biotechnologies)
- Pensar Medical, LLC: 1 (https://510kreport.com/company/pensar-medical)
- Convatec Limited: 1 (https://510kreport.com/company/convatec)
- Zhejiang Longterm Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-longterm-medical-technology)
- Alleva Medical, Ltd.: 1 (https://510kreport.com/company/alleva-medical)
- Molnlycke Health Care Us, LLC: 1 (https://510kreport.com/company/molnlycke-health-care-us)
- Applied Tissue Technologies, LLC: 1 (https://510kreport.com/company/applied-tissue-technologies)

## Its most-cited devices
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), cited by 8
- K180698: PICO 7 Single Use Negative Pressure Wound Therapy System (2018), cited by 3
- K163387: PICO Single Use Negative Pressure Wound Therapy System (2017), cited by 3
- K172005: PICO 7 Single Use Negative Pressure Wound Therapy System (2018), cited by 2
- K153209: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,  RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply (2016), cited by 2
- K172521: PICO Single Use Negative Pressure Wound Therapy System (2017), cited by 1

## Recent decisions
- K261982: RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (Oct 23, 2026)
- K261338: RENASYS DYNAFLOW Kit (66807741) (Sep 11, 2026)
- K260646: Renasys Edge (66803126) (May 27, 2026)
- K251826: RENASYS WOUND+  Dressing Kit with AIRLOCK Technology (Sep 11, 2025)
- K243576: RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port (Feb 18, 2025)
- K242146: BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (Dec 17, 2024)
- K231939: Renasys Edge (May 24, 2024)
- K223526: ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing (Aug 18, 2023)

Source page: https://510kreport.com/company/smith-nephew-medical