Smith & Nephew Medical, Ltd.: FDA clearances and approvals
Smith & Nephew Medical, Ltd. has 12 FDA 510(k) clearances (first 1989, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 164 days. Since 2017 its median was 141 days, against 227 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Smith & Nephew Medical, Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 259 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 272 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 329 |
| 2025 | 2 | 90 |
| 2026 | 2 | 115 |
Review time against the same product codes
Since 2017, Smith & Nephew Medical, Ltd.'s cleared 510(k)s took a median 141 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 227 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 7 | 7 |
| LYY | Latex Patient Examination Glove | 3 | 3 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
Review panels
Most recent Smith & Nephew Medical, Ltd. 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 |
| K231939 | Renasys Edge | OMP | 2024-05-24 | 329 |
| K190756 | IODOFLEX | FRO | 2019-12-20 | 270 |
| K190730 | IODOSORB | FRO | 2019-12-20 | 274 |
| 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 | OMP | 2016-08-04 | 273 |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | OMP | 2016-01-28 | 245 |
| K891444 | PERRY* STERILE X-AM* GLOVES | LYY | 1989-09-19 | 188 |
2 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 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, Ltd. have?
Smith & Nephew Medical, Ltd. has 12 FDA 510(k) clearances (first 1989, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear Smith & Nephew Medical, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Smith & Nephew Medical, Ltd.'s cleared 510(k)s is 164 days. Since 2017: 141 days, versus 227 days for all cleared 510(k)s in the same product codes.
What devices does Smith & Nephew Medical, Ltd. make?
Its most frequent FDA product codes are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 7); LYY (Latex Patient Examination Glove, 3); FRO (Dressing, Wound, Drug, 2).
Has Smith & Nephew Medical, Ltd. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Smith & Nephew Medical, Ltd; the most recent began 2024-10-02. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Smith & Nephew Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OMP, Smith & Nephew Medical, Ltd.'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.