Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acorn Group, Inc. — 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) |
|---|---|---|---|---|---|
| K914362 | TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS | Acorn Group, Inc. | 1992-04-29 | 211 | 0 |
| K912905 | LARYNGOSCOPE | Acorn Group, Inc. | 1991-09-30 | 90 | 0 |
| K904126 | VISIRASER | Acorn Group, Inc. | 1990-10-30 | 54 | 0 |
| K900430 | IRRIGATION AND SUCTION APPARATUS | Acorn Group, Inc. | 1990-06-05 | 126 | 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