Smith & Nephew Medical Limited: FDA filings under this applicant name
FDA lists 30 510(k) clearances under 3 spellings of the applicant name “Smith & Nephew Medical Limited” (first 2016, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 158 days. Since 2017 the median was 152 days, against 210 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 4 | 253 |
| 2017 | 3 | 30 |
| 2018 | 4 | 100 |
| 2019 | 6 | 252 |
| 2020 | 1 | 88 |
| 2021 | 1 | 358 |
| 2022 | 2 | 266 |
| 2023 | 3 | 410 |
| 2024 | 2 | 238 |
| 2025 | 2 | 90 |
| 2026 | 2 | 115 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Smith & Nephew Medical Limited took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 22 | 22 |
| FRO | Dressing, Wound, Drug | 5 | 5 |
| FQH | Lavage, Jet | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| QFC | Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | 1 | 1 |
Review panels
Most recent Smith & Nephew Medical Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741) | OMP | 2026-09-11 | 141 |
| K260646 | RENASYS EDGE (66803126) | OMP | 2026-05-27 | 89 |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | OMP | 2025-09-11 | 90 |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | OMP | 2025-02-18 | 91 |
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | KGN | 2024-12-17 | 147 |
| K231939 | Renasys Edge | OMP | 2024-05-24 | 329 |
| 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 | FRO | 2023-08-18 | 268 |
| K220964 | VERSAJET Hydrosurgery System (III) | FQH | 2023-05-16 | 410 |
| K213853 | RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large | OMP | 2023-02-10 | 427 |
| K223041 | Renasys Edge (66803126) | OMP | 2022-11-22 | 54 |
20 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2024-10-02.
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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Smith & Nephew Medical Limited (19)
- Smith & Nephew Medical, Ltd. (9)
- Smith and Nephew Medical Limited (2)
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 United, Inc. (34 510(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 Medical Limited?
FDA lists 30 510(k) clearances under 3 spellings of the applicant name “Smith & Nephew Medical Limited” (first 2016, latest 2026), across 5 product codes in 2 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 Medical Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew Medical Limited is 158 days. Since 2017: 152 days, versus 210 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Smith & Nephew Medical Limited?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 22); FRO (Dressing, Wound, Drug, 5); FQH (Lavage, Jet, 1).
Next steps
- See all 30 Smith & Nephew Medical Limited clearances with predicates and recalls
- Run predicate analysis for product code OMP, Smith & Nephew Medical Limited'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.