# Churchill Medical Systems, Inc.

- Location (FDA's records): Dover, NH
- FDA decisions: 12 (1988–2004): 12 510(k) clearances
- Product codes: FPA (7), FPB (2), KPE (1), FPK (1), FMG (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Secure Medical Products, Inc.: 1 (https://510kreport.com/company/secure-medical-products)
- Stedim, Inc.: 1 (https://510kreport.com/company/stedim)
- Pacific Device, Inc.: 1 (https://510kreport.com/company/pacific-device)
- I-Flow Corp.: 1 (https://510kreport.com/company/i-flow)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Ohmeda Medical: 1 (https://510kreport.com/company/ohmeda-medical)

## Firms that cite its devices most
- Victus, Inc.: 5 (https://510kreport.com/company/victus)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Acta Medical, LLC: 1 (https://510kreport.com/company/acta-medical)

## Its most-cited devices
- K041038: Churchill Medical Dual Chamber Empty Container (2004), cited by 2
- K894954: .22 & 1.2 Micron IV Filters (1989), cited by 1
- K021395: Modification to 30 Extension Set (2002), cited by 1
- K884370: CMS IV Extension Sets (1988), cited by 1
- K011336: Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock (2001), cited by 1
- K896333: CMS IV Filters (1990), cited by 1

## Recent decisions
- K041038: Churchill Medical Dual Chamber Empty Container (Dec 21, 2004)
- K021395: Modification to 30 Extension Set (May 13, 2002)
- K013949: Universal Vial Access Spike with Needleless Connector (Mar 27, 2002)
- K020544: Wing Safe Infusion Set 20 GA, SHS2000 Series; Wing Safe Infusion Set 19 GA, SHS1900 Series; Wing Safe Infusion Set 22 GA (Mar 12, 2002)
- K013950: Vented Vial Access Device (Jan 10, 2002)
- K012157: Churchill Medical Systems Stopcock (Sep 11, 2001)
- K011888: Pressure Activated Check Valve (Sep 10, 2001)
- K011336: Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock (Jun 12, 2001)

Source page: https://510kreport.com/company/churchill-medical-systems