Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Merrimack Laboratories — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
515 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833528 | CARBON DIOXIDE LASER ML 825 | Merrimack Laboratories | 1985-02-19 | 515 | 0 |
| K833483 | ENDOSCOPIC COUPLER | Merrimack Laboratories | 1984-02-10 | 126 | 0 |
| K827963 | MODEL ML-850 | Merrimack Laboratories | 1982-09-13 | 24 | 0 |
| K827506 | MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERY | Merrimack Laboratories | 1982-06-11 | 38 | 0 |
| K827442 | ML-810 CARBON DIOXIDE LASER SYSTEM | Merrimack Laboratories | 1982-05-19 | 33 | 0 |
| K800227 | ML-800 CO2 | Merrimack Laboratories | 1980-03-03 | 27 | 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