Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LRL · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072690 | HEMAWAY SEAT | Hemaway, LLC | 2007-12-07 | 74 | 0 |
| K932396 | PERI-COMFORT(TM) SEATING CUSHION | Chi'Am Intl. | 1993-09-30 | 135 | 0 |
| K864470 | HEMOREST(TM) | Health Aid Products | 1987-06-23 | 223 | 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