Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
O-Two Medical Technologies, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
331 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | 2018-08-29 | 331 | 0 |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | 2015-03-16 | 276 | 3 |
| K113687 | EQUINOX RELIEVE | O-Two Medical Technologies, Inc. | 2012-04-30 | 137 | 0 |
| K112546 | O_TWO CPAP SYSTEM | O-Two Medical Technologies, Inc. | 2011-12-27 | 117 | 0 |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | O-Two Medical Technologies, Inc. | 2010-05-06 | 140 | 0 |
| K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | O-Two Medical Technologies, Inc. | 2009-03-06 | 298 | 0 |
| K051469 | CAREVENT ATV+ AND CAREVENT MRI | O-Two Medical Technologies, Inc. | 2005-09-28 | 117 | 0 |
| K051889 | CAREVENT CA AND DRA | O-Two Medical Technologies, Inc. | 2005-08-30 | 49 | 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