Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Altus Medical, 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) |
|---|---|---|---|---|---|
| K033768 | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE | Altus Medical, Inc. | 2004-02-17 | 76 | 0 |
| K023954 | ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES | Altus Medical, Inc. | 2003-03-18 | 111 | 0 |
| K022226 | ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I | Altus Medical, Inc. | 2002-10-08 | 90 | 0 |
| K014040 | FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, | Altus Medical, Inc. | 2002-06-03 | 178 | 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