Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZK — Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962528 | OLYMPUS MOBILE CHAIR/COUCH | Keymed (Medical & Industrial Equipment), Ltd. | 1996-12-12 | 168 | 0 |
| K842030 | NEUTRAL POS-CHAIR SURGEON CHAIR | Neutral Pos-Chair Co. | 1984-07-23 | 66 | 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