Smith & Nephew United, Inc.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Smith & Nephew United, Inc.” (first 1989, latest 1996), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 64 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Smith+Nephew, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KMF | Bandage, Liquid | 7 | 7 |
| KGX | Tape And Bandage, Adhesive | 6 | 6 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 3 | 3 |
| NAD | Dressing, Wound, Occlusive | 3 | 3 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| KOX | Solvent, Adhesive Tape | 2 | 2 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 2 | 2 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (32)
- General Hospital (1)
- Neurology (1)
Most recent Smith & Nephew United, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963096 | ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING | KMF | 1996-10-25 | 77 |
| K961775 | PROFORE FOUR-LAYER BANDAGE SYSTEM KIT | EFQ | 1996-07-16 | 69 |
| K945330 | ALLEVYN ADHESIVE | KMF | 1995-02-09 | 100 |
| K943619 | CAVI-CARE CONFORMING FOAM DRESSING | KMF | 1994-08-19 | 23 |
| K942748 | INTRASITE | NAE | 1994-06-29 | 19 |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | NAE | 1994-02-15 | 77 |
| K935803 | CICA-CARE SILICONE GEL SHEET | MDA | 1994-02-03 | 63 |
| K932263 | SOLOSITE DERMAL WOUND GEL | MGQ | 1993-10-01 | 164 |
| K926508 | INTRASITE GEL | NAE | 1993-07-13 | 195 |
| K922897 | STRAPPAL | KGX | 1992-09-15 | 91 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew United, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Smith & Nephew, Inc. (556 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew Medical Limited (30 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(k)s)
- Smith River Biologicals (12 510(k)s)
- Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
- Smith & Nephew, Inc., Orthopaedic Div. (10 510(k)s)
- Smith & Nephew Perry (10 510(k)s)
- Smith & Nephew, Mpl Division (9 510(k)s)
- Smith & Nephew Inc., Endoscopy Division (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew United, Inc.?
FDA lists 34 510(k) clearances under the applicant name “Smith & Nephew United, Inc.” (first 1989, latest 1996), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Smith & Nephew United, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew United, Inc. is 64 days.
Which FDA product codes appear under Smith & Nephew United, Inc.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 7); KGX (Tape And Bandage, Adhesive, 6); KOZ (Beads, Hydrophilic, For Wound Exudate Absorption, 3).
Next steps
- See all 34 Smith & Nephew United, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Smith & Nephew United, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.