Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew Medical, Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
270 daysmedian FDA review time
329 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | 2026-05-27 | 89 | 0 |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | 2025-09-11 | 90 | 0 |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and | Smith & Nephew Medical, Ltd. | 2025-02-18 | 91 | 0 |
| K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024-05-24 | 329 | 0 |
| K190730 | IODOSORB | Smith & Nephew Medical, Ltd. | 2019-12-20 | 274 | 0 |
| K190756 | IODOFLEX | Smith & Nephew Medical, Ltd. | 2019-12-20 | 270 | 0 |
| K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH | Smith & Nephew Medical, Ltd. | 2016-08-04 | 273 | 0 |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016-01-28 | 245 | 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