Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Atlas Researches , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862747 | 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS | Atlas Researches , Ltd. | 1988-08-05 | 746 | 0 |
| K810881 | EMG 3510/EMG 3510D MYOFEEDBACK MONITORS | Atlas Researches , Ltd. | 1981-05-27 | 57 | 0 |
| K810880 | AR-1 PHYSIOLOGICAL PRODESSOR | Atlas Researches , Ltd. | 1981-05-27 | 57 | 0 |
| K810882 | ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A | Atlas Researches , Ltd. | 1981-05-27 | 57 | 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