510(k) Report

FDA applicant

Churchill Medical Systems, Inc.

Dover, NH12 decisions1988–200430 recalls

FDA records 12 decisions for Churchill Medical Systems, Inc. (Dover, NH) from 1988 to 2004: 12 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FPB (Filter, Infusion Line). Its devices cite 8 predicates, 0 of them its own earlier devices. 30 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Churchill Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Churchill Medical Systems, Inc. since 2007.

Recalls per year

3in 2017

2009: 12010: 122014: 12015: 122016: 12017: 3
2007high 12 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Churchill Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular7decisions
  • FPBFilter, Infusion Line2decisions
  • KPEContainer, I.V.1decision
  • FPKTubing, Fluid Delivery1decision
  • FMGStopcock, I.V. Set1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041038Churchill Medical Dual Chamber Empty ContainerChurchill Medical Systems, Inc. · 20042cite it
  • K894954.22 & 1.2 Micron IV FiltersChurchill Medical Systems, Inc. · 19891cites it
  • K021395Modification to 30 Extension SetChurchill Medical Systems, Inc. · 20021cites it
  • K884370CMS IV Extension SetsChurchill Medical Systems, Inc. · 19881cites it
  • K011336Primary Solution Set with Universal Spike, Injection Site and Male Luer LockChurchill Medical Systems, Inc. · 20011cites it
  • K896333CMS IV FiltersChurchill Medical Systems, Inc. · 19901cites it

What has FDA decided for it lately?

  • K041038Churchill Medical Dual Chamber Empty ContainerChurchill Medical Systems, Inc. · 2004
  • K021395Modification to 30 Extension SetChurchill Medical Systems, Inc. · 200218 recalls
  • K013949Universal Vial Access Spike with Needleless ConnectorChurchill Medical Systems, Inc. · 2002
  • K020544Wing Safe Infusion Set 20 GA, SHS2000 Series; Wing Safe Infusion Set 19 GA, SHS1900 Series; Wing Safe…Churchill Medical Systems, Inc. · 20021 recall
  • K013950Vented Vial Access DeviceChurchill Medical Systems, Inc. · 2002
  • K012157Churchill Medical Systems StopcockChurchill Medical Systems, Inc. · 20011 recall
  • K011888Pressure Activated Check ValveChurchill Medical Systems, Inc. · 2001
  • K011336Primary Solution Set with Universal Spike, Injection Site and Male Luer LockChurchill Medical Systems, Inc. · 20019 recalls

All 12 as Churchill Medical Systems, Inc. →

What has been recalled?

30 recalls linked to its devices; the latest:

  • K882503Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when…Oct 3, 2017Class II
  • K0121573-Way Standardbore Stopcock. Product Code: AMS-100.Jul 24, 2017Class II
  • K021395AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to…Feb 20, 2017Class II
  • K021395AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product…Nov 18, 2016Class II
  • K0213958" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer…Jan 15, 2015Class II
  • K0213957" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to…Jan 15, 2015Class II

Other applicant names beginning “Churchill”

FDA records each applicant name separately; these may or may not be the same firm.

Churchill Corp. 35