Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mesa Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
475 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925210 | 90DX MULTITEST METER, MODIFICATION | Mesa Medical, Inc. | 1994-01-25 | 475 | 0 |
| K882032 | MODEL 90DX MULTITEST METER | Mesa Medical, Inc. | 1988-08-11 | 87 | 0 |
| K870811 | MODEL 102 PH METER | Mesa Medical, Inc. | 1987-03-24 | 21 | 0 |
| K852749 | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT | Mesa Medical, Inc. | 1985-09-10 | 75 | 0 |
| K843520 | WAREXIN RECOMMENDED ALTERNATIVE DIALYZ | Mesa Medical, Inc. | 1984-10-04 | 27 | 0 |
| K834447 | ECHO MM1000 | Mesa Medical, Inc. | 1984-03-23 | 98 | 0 |
| K821383 | ECHO, MODEL MM-1000 | Mesa Medical, Inc. | 1982-06-23 | 44 | 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