Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Merced Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
76 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915810 | MER BAG | Merced Medical, Inc. | 1992-03-09 | 76 | 0 |
| K911622 | CPR BAG | Merced Medical, Inc. | 1991-05-20 | 39 | 0 |
| K900569 | THERMOPROBE 210 | Merced Medical, Inc. | 1990-04-10 | 62 | 0 |
| K901026 | MJ PERCUSSOR(TM) | Merced Medical, Inc. | 1990-03-15 | 9 | 0 |
| K790642 | LEY ELECTRO-SURGICAL UNITS | Merced Medical, Inc. | 1979-05-08 | 39 | 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