Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medivators, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
342 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223040 | Endo SmartCap | Medivators, Inc. | 2023-03-01 | 153 | 0 |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Medivators, Inc. | 2022-01-14 | 36 | 0 |
| K172677 | Advantage Plus Pass-Thru | Medivators, Inc. | 2017-12-19 | 105 | 1 |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | Medivators, Inc. | 2016-12-21 | 142 | 0 |
| K160846 | AmplifEYE | Medivators, Inc. | 2016-07-14 | 108 | 0 |
| K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016-03-11 | 200 | 0 |
| K151522 | DEFENDO Bronchoscopy Suction Valve | Medivators, Inc. | 2015-09-17 | 104 | 0 |
| K133724 | MINNCARE HD | Medivators, Inc. | 2014-08-27 | 264 | 0 |
| K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | Medivators, Inc. | 2000-08-17 | 342 | 0 |
| K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Medivators, Inc. | 1994-02-22 | 890 | 1 |
| K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Medivators, Inc. | 1987-02-03 | 223 | 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