Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jay H. Geller — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971658 | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | Jay H. Geller | 1997-05-23 | 39 | 0 |
| K942326 | HUMAN C5 RID KITS | Jay H. Geller | 1995-08-24 | 468 | 0 |
| K950015 | HUMAN PROTEIN C RID TEST KIT | Jay H. Geller | 1995-03-06 | 62 | 0 |
| K943334 | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT | Jay H. Geller | 1994-10-05 | 85 | 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