Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Andros Analyzers, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
95 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903806 | ANGIOTEC IMAGE MANAGEMENT SYSTEM | Andros Analyzers, Inc. | 1990-11-23 | 95 | 0 |
| K893476 | ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. | Andros Analyzers, Inc. | 1989-06-23 | 50 | 0 |
| K892869 | ANGIOTEC ZX DIGITAL IMAGE PROCESSOR | Andros Analyzers, Inc. | 1989-05-26 | 37 | 0 |
| K891485 | ANGIOTEC FMX-2220 SYSTEM | Andros Analyzers, Inc. | 1989-05-05 | 49 | 0 |
| K852463 | ANDROS ANALYZERS AIRWAY ADAPTER | Andros Analyzers, Inc. | 1985-07-08 | 28 | 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