Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew Medical Limited · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
410 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Smith & Nephew Medical Limited | 2024-12-17 | 147 | 0 |
| K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Compo | Smith & Nephew Medical Limited | 2023-08-18 | 268 | 0 |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | 2023-05-16 | 410 | 0 |
| K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022-11-22 | 54 | 3 |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Tr | Smith & Nephew Medical Limited | 2022-01-14 | 479 | 0 |
| K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PI | Smith Nephew Medical Limited | 2022-01-05 | 250 | 0 |
| K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PI | Smith & Nephew Medical Limited | 2020-10-30 | 88 | 0 |
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2019-12-05 | 157 | 0 |
| K181822 | RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited | 2019-03-21 | 255 | 0 |
| K182323 | PICO 7Y Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2019-01-18 | 144 | 0 |
| K181204 | RENASYS Y-Connector; RENASYS TOUCH | Smith & Nephew Medical Limited | 2019-01-10 | 248 | 0 |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-08-21 | 158 | 0 |
| K180618 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-04-20 | 42 | 0 |
| K180614 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-04-06 | 29 | 0 |
| K172005 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-02-02 | 214 | 0 |
| K172521 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017-09-20 | 30 | 0 |
| K172519 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017-09-15 | 25 | 0 |
| K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017-04-18 | 137 | 0 |
| K153723 | ACTICOAT Surgical Dressing | Smith & Nephew Medical Limited | 2016-09-14 | 261 | 0 |
| K161289 | DURAFIBER Ag | Smith & Nephew Medical Limited | 2016-08-03 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda