# Medivators, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 13 (1987–2023): 13 510(k) clearances
- Names in FDA's records: Medivators, Inc. (11); Medivators (2)
- Product codes: FEB (4), OCX (2), FED (1), NIH (1), NVE (1), JOJ (1), KTI (1), MED (1), FAJ (1)
- 510(k) review time since 2016: median 131 days, against 138 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 15 (1 its own); citations of its devices by later devices: 11 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Byrne Medical, Inc.: 4 (https://510kreport.com/company/byrne-medical)
- Medivators Reprocessing Systems: 3 (https://510kreport.com/company/medivators-reprocessing-systems)
- Boddingtons Plastics, Ltd.: 2 (https://510kreport.com/company/boddingtons-plastics)
- Krd Co., Ltd.: 1 (https://510kreport.com/company/krd)
- Integrated Biomedical Technology, Inc.: 1 (https://510kreport.com/company/integrated-biomedical-technology)
- Minntech Corp.: 1 (https://510kreport.com/company/minntech)
- United States Endoscopy Group, Inc.: 1 (https://510kreport.com/company/united-states-endoscopy-group)
- Olympus Corp.: 1 (https://510kreport.com/company/olympus)

## Firms that cite its devices most
- Minntech Corp.: 2 (https://510kreport.com/company/minntech)
- Cs Medical, LLC: 2 (https://510kreport.com/company/cs-medical)
- Medivators Reprocessing Systems: 1 (https://510kreport.com/company/medivators-reprocessing-systems)
- Advanced Sterilization Products: 1 (https://510kreport.com/company/advanced-sterilization-products)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Serim Research Corp.: 1 (https://510kreport.com/company/serim-research)
- Partnership Medical Limited: 1 (https://510kreport.com/company/partnership-medical)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)

## Its most-cited devices
- K914145: DSD-91(TM) Disinfector for Flexible Endoscopes (1994), cited by 5
- K152394: Rapicide PA High-Level Disinfectant Test Strips (2016), cited by 2
- K993042: Medivators 5 Minute High-Level Disinfectant (2000), cited by 2
- K140753: Endo Smart Bottle, Rinse and Insufflation System (2014), cited by 1
- K162128: Scope Buddy Plus Endoscope Flushing Aid (2016), cited by 1

## Recent decisions
- K231418: ENDOGATOR™ Hybrid Irrigation Tubing (Aug 14, 2023)
- K223040: Endo SmartCap (Mar 1, 2023)
- K213833: SCOPE BUDDY PLUS Endoscope Flushing Aid (Jan 14, 2022)
- K172677: Advantage Plus Pass-Thru (Dec 19, 2017)
- K162128: Scope Buddy Plus Endoscope Flushing Aid (Dec 21, 2016)
- K160846: AmplifEYE (Jul 14, 2016)
- K152394: Rapicide PA High-Level Disinfectant Test Strips (Mar 11, 2016)
- K151522: DEFENDO Bronchoscopy Suction Valve (Sep 17, 2015)

Source page: https://510kreport.com/company/medivators
