Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Analytical Industries, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053407 | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M | Analytical Industries, Inc. | 2006-04-05 | 119 | 0 |
| K002382 | 'ALL 2000' % OXYGEN ANALYZER | Analytical Industries, Inc. | 2001-03-14 | 222 | 0 |
| K952736 | PERCENT OXYGEN SENSOR | Analytical Industries, Inc. | 1995-10-18 | 125 | 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