Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Breathe Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
287 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130037 | BREATHE CPAP SYSTEM | Breathe Technologies, Inc. | 2013-05-17 | 130 | 0 |
| K103345 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | 2011-02-11 | 88 | 0 |
| K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | 2010-12-02 | 91 | 0 |
| K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | Breathe Technologies, Inc. | 2010-04-23 | 58 | 0 |
| K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | Breathe Technologies, Inc. | 2009-07-20 | 287 | 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