# Bayer Medical Care, Inc.

- Location (FDA's records): Indianaola, PA
- FDA decisions: 11 (2015–2026): 11 510(k) clearances
- Product codes: DXT (8), PQH (2), HAW (1)
- 510(k) review time since 2016: median 108 days, against 96 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medrad, Inc.: 3 (https://510kreport.com/company/medrad)
- Voyager Therapeutics, Inc.: 1 (https://510kreport.com/company/voyager-therapeutics)
- Bayer U.S., LLC: 1 (https://510kreport.com/company/bayer-us)
- Medrad, Inc. / Bayer Medical Care, Inc.: 1 (https://510kreport.com/company/medrad-bayer-medical-care)

## Firms that cite its devices most
- Ulrich GmbH & Co. KG: 1 (https://510kreport.com/company/ulrich)

## Its most-cited devices
- K182273: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), cited by 2
- K182276: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit (2018), cited by 1
- K173773: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), cited by 1
- K200280: MEDRAD Imaging Bulk Package Transfer Spike (2020), cited by 1
- K143538: MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit (2015), cited by 1

## Recent decisions
- K262043: MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike (Oct 6, 2026)
- K253688: MEDRAD® Imaging Bulk Package Transfer Spike (Jun 12, 2026)
- K252891: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (Feb 13, 2026)
- K250893: Ball Joint Guide Array (66295) (Sep 4, 2025)
- K200280: MEDRAD Imaging Bulk Package Transfer Spike (Jul 30, 2020)
- K192370: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (Dec 13, 2019)
- K193028: MEDRAD Mark 7 Arterion Injection System (Dec 5, 2019)
- K182276: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit (Nov 1, 2018)

Source page: https://510kreport.com/company/bayer-medical-care