Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sensidyne, Inc. · 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) |
|---|---|---|---|---|---|
| K021246 | SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 | Sensidyne, Inc. | 2002-05-13 | 24 | 0 |
| K011974 | SENSAID | Sensidyne, Inc. | 2002-02-12 | 232 | 0 |
| K010382 | 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I | Sensidyne, Inc. | 2001-03-01 | 21 | 0 |
| K000700 | SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR | Sensidyne, Inc. | 2000-08-31 | 183 | 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