Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aztec Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
45 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801939 | RHYTIDOMETER | Aztec Medical Products, Inc. | 1980-09-26 | 45 | 0 |
| K801937 | BLEPHAROMETER | Aztec Medical Products, Inc. | 1980-09-16 | 35 | 0 |
| K801938 | RHINOMETER | Aztec Medical Products, Inc. | 1980-09-09 | 28 | 0 |
| K792608 | TEGTMEIER MAMMOMETER | Aztec Medical Products, Inc. | 1980-01-04 | 17 | 0 |
| K791221 | TEGTMEIER MAMMOMETER | Aztec Medical Products, Inc. | 1979-07-03 | 0 | 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