Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acme-Monaco Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
268 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113162 | SLIDEWIRETM(TRADEMARK PENDING) | Acme-Monaco Corp. | 2012-07-20 | 268 | 0 |
| K920884 | GUIDEWIRES, VARIOUS TYPES | Acme-Monaco Corp. | 1992-08-19 | 230 | 0 |
| K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) | Acme-Monaco Corp. | 1990-04-09 | 188 | 0 |
| K895483 | ACME COATED ORTHODONTIC ARCHWIRE | Acme-Monaco Corp. | 1990-01-29 | 140 | 0 |
| K883763 | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH | Acme-Monaco Corp. | 1988-11-18 | 73 | 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