Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Amdev, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
85 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904726 | LYTENING TM 6/R | Amdev, Inc. | 1990-12-18 | 62 | 0 |
| K890524 | APEC GLUCOSE ANALYZER | Amdev, Inc. | 1989-03-15 | 41 | 0 |
| K884731 | LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | Amdev, Inc. | 1989-02-03 | 85 | 0 |
| K880917 | LYTENING 5 | Amdev, Inc. | 1988-05-27 | 85 | 0 |
| K863521 | LYTENING 2 | Amdev, Inc. | 1986-11-05 | 56 | 0 |
| K853832 | LYTENING 1 | Amdev, Inc. | 1985-10-04 | 21 | 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