CMS IV Extension Sets

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K884370 ↗

FDA Product Code

FPK

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 30 IV Extension Set W/Two Male Luer Locks

  Class II

  FDA 510(k) K882503 Active Cleared 25 Aug 1988

• Churchill Medical Systems Stopcock

  Class II

  FDA 510(k) K012157 Active Cleared 11 Sep 2001

• Cms IV Filters

  Class II

  FDA 510(k) K896333 Active Cleared 11 Jan 1990

• Universal Vial Access Spike with Needleless Connector

  Class II

  FDA 510(k) K013949 Active Cleared 27 Mar 2002

• Modification to 30 Extension Set

  Class II

  FDA 510(k) K021395 Active Cleared 13 May 2002

• Primary Solution Set With Universal Spike, Injection Site And Male Luer Lock

  Class II

  FDA 510(k) K011336 Active Cleared 12 Jun 2001

See all devices from Churchill Medical Systems, Inc. →

• What are CMS IV Extension Sets used for?

  CMS IV Extension Sets are tubing devices used for fluid delivery in general hospital settings, as indicated by their classification under product code FPK and regulation number 880.5440, and their intended use for general hospital applications.

• How are CMS IV Extension Sets supplied regarding sterility and use?

  CMS IV Extension Sets are supplied as non-sterile and may be configured for either reusable or single-use extension sets, though specific sterility and reuse details depend on the individual configuration and are not explicitly defined in the provided data.

• What regulatory pathway was used to clear CMS IV Extension Sets?

  CMS IV Extension Sets were cleared via the traditional 510(k) pathway under K884370 by Churchill Medical Systems, Inc., with a decision date of November 7, 1988, based on substantial equivalence to a predicate device.