Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Curative Medical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
293 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141354 | NAVAJO PTA BALLOON DILATATION CATHETER | Curative Medical, Inc. | 2015-01-30 | 252 | 0 |
| K130828 | K SERIES CPAP SYSTEMS | Curative Medical, Inc. | 2014-01-13 | 293 | 0 |
| K131702 | K SERIES CPAP SYSTEMS | Curative Medical, Inc. | 2013-12-06 | 178 | 0 |
| K130663 | BESTFIT2 NASAL MASK | Curative Medical, Inc. | 2013-09-27 | 199 | 0 |
| K123897 | K SERIES CPAP SYSTEMS | Curative Medical, Inc. | 2013-03-13 | 85 | 0 |
| K120285 | K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER | Curative Medical, Inc. | 2012-07-02 | 153 | 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