Smith & Nephew Medical Limited: FDA clearances and approvals
Smith & Nephew Medical Limited has 20 FDA 510(k) clearances (first 2016, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time: 152 days. Since 2017 its median was 152 days, against 210 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 174 |
| 2017 | 3 | 30 |
| 2018 | 4 | 100 |
| 2019 | 4 | 202 |
| 2020 | 1 | 88 |
| 2021 | 0 | — |
| 2022 | 3 | 250 |
| 2023 | 2 | 339 |
| 2024 | 1 | 147 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Smith & Nephew Medical Limited's cleared 510(k)s 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 | 15 | 15 |
| FRO | Dressing, Wound, Drug | 3 | 3 |
| FQH | Lavage, Jet | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
Review panels
Most recent Smith & Nephew Medical Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | KGN | 2024-12-17 | 147 |
| 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 |
| K223041 | Renasys Edge (66803126) | OMP | 2022-11-22 | 54 |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing | OMP | 2022-01-14 | 479 |
| K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs | OMP | 2022-01-05 | 250 |
| K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack | OMP | 2020-10-30 | 88 |
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | OMP | 2019-12-05 | 157 |
| K181822 | RENASYS Touch; RENASYS Y-Connector | OMP | 2019-03-21 | 255 |
| K182323 | PICO 7Y Single Use Negative Pressure Wound Therapy System | OMP | 2019-01-18 | 144 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew Medical Limited.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Smith & Nephew Medical Limited have?
Smith & Nephew Medical Limited has 20 FDA 510(k) clearances (first 2016, latest 2024), across 4 product codes in 2 review panels.
How long does FDA take to clear Smith & Nephew Medical Limited's 510(k)s?
The median time from FDA receipt to decision across Smith & Nephew Medical Limited's cleared 510(k)s is 152 days. Since 2017: 152 days, versus 210 days for all cleared 510(k)s in the same product codes.
What devices does Smith & Nephew Medical Limited make?
Its most frequent FDA product codes are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 15); FRO (Dressing, Wound, Drug, 3); FQH (Lavage, Jet, 1).
Has Smith & Nephew Medical Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Smith & Nephew Medical Limited. Related entities may recall under other names.
Next steps
- See all 20 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.