Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IPM · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
20 daysmedian FDA review time
90 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872488 | ELASTO-GEL CAST & SPLINT PADS | Southwest Technologies, Inc. | 1987-09-21 | 90 | 0 |
| K823399 | COVER LIMB | Orthopedic Systems, Inc. | 1982-11-29 | 17 | 0 |
| K801627 | COVER, LIMB | The Owenby Co. | 1980-07-28 | 13 | 0 |
| K780905 | LIMB COVER | Hydro-Med Products, Inc. | 1978-08-14 | 73 | 0 |
| K770223 | HEAVY FOAM HEEL & ELBOW PROTECTORS | Robert R. Moore | 1977-02-23 | 20 | 0 |
| K761114 | FOAM SLIPPERS | Fred Sammons, Inc. | 1976-12-02 | 13 | 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