Churchill Medical Dual Chamber Empty Container

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K041038 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

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

• CMS IV Extension Sets

  Class II

  FDA 510(k) K884370 Active Cleared 7 Nov 1988

• Modification to 30 Extension Set

  Class II

  FDA 510(k) K021395 Active Cleared 13 May 2002

See all devices from Churchill Medical Systems, Inc. →

• What is the Churchill Medical Dual Chamber Empty Container used for?

  This device is a dual chamber empty container designed for intravenous use, as defined in the nomenclature authority for IV containers. It is intended to hold fluids or medications for IV administration in general hospital settings, providing a dual-chamber design for separating components until use.

• Is the Churchill Medical Dual Chamber Empty Container sterile or non-sterile when supplied?

  The container is supplied non-sterile, as stated in the device specifications. This means it requires sterilization by the user before use in clinical applications, consistent with its intended single-use design in general hospital environments.

• Can the Churchill Medical Dual Chamber Empty Container be reused after initial use?

  No, the device is intended for single-use only. Reuse is not recommended or supported by its design or labeling, as it is cleared as a single-use container to prevent contamination, ensure patient safety, and maintain integrity of the dual-chamber system.

• What regulatory pathway was used to clear the Churchill Medical Dual Chamber Empty Container?

  The device was cleared via the FDA 510(k) process under submission number K041038, which determined it to be substantially equivalent to a legally marketed predicate device. This is indicated by the decision code SESE and decision description 'Substantially Equivalent' in the authorization data.

• What class is the Churchill Medical Dual Chamber Empty Container classified as, and what does this imply about its risk level?

  The device is classified as a Class II medical device, as indicated by the device_class=2 field in the openfda data. Class II devices are subject to special controls to ensure safety and effectiveness, reflecting a moderate risk level that requires more regulatory oversight than Class I but less than Class III devices.