Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMR · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
46 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871475 | SOLOLIFT - PATIENT TRANSFER STRETCHER | Adel Medical , Ltd. | 1987-05-11 | 27 | 0 |
| K801796 | THE COMFORT LIFT | Gettner Enterprises, Inc. | 1980-08-13 | 15 | 0 |
| K800373 | TENDERLIFT | Competent Design | 1980-03-12 | 21 | 0 |
| K792318 | SKIL-CARE TURN AND HOLD PAD | Skil-Care Corp. | 1979-12-20 | 31 | 0 |
| K770499 | PATIENT TURNING AND REPOSITIONING G DEV. | Patient Healthguards Corp. | 1977-04-29 | 46 | 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