Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A. Henniss — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905445 | ADSON-BECKMAN RETRACTOR, SPINAL | A. Henniss | 1991-01-25 | 52 | 0 |
| K902703 | CRANIOTOME BLADE OR DRILL BIT | A. Henniss | 1990-11-13 | 146 | 0 |
| K902567 | STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES | A. Henniss | 1990-07-10 | 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