Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FRK · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896275 | JEDMED J-II CHAIR | Jedmed Instrument Co. | 1989-12-18 | 49 | 0 |
| K791016 | ULTICARE 2500 TREATMENT CHAIR | American Health Care Industries, Inc. | 1979-06-27 | 26 | 0 |
| K790955 | COVER GARD | Fem-Gard, Inc. | 1979-06-20 | 29 | 0 |
| K790954 | HEEL GARD | Fem-Gard, Inc. | 1979-06-20 | 29 | 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