Cleared Abbreviated

K041038 - CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER

K041038 is an FDA 510(k) clearance for CHURCHILL MEDICAL DUAL CHAMBER EMPTY CO..., manufactured by Churchill Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Abbreviated 510(k) pathway after a 243-day FDA review.

K041038 · Churchill Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
243d
Days
Class 2
Risk

K041038 is an FDA 510(k) clearance for the CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Churchill Medical Systems, Inc. (Dover, US). The FDA issued a Cleared decision on December 21, 2004 after a review of 243 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041038

510(k) Number K041038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date December 21, 2004
Days to Decision 243 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 129d · This submission: 243d
Pathway characteristics
Standards-based clearance path.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KPE Container, I.v.

All 104
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K041038.
ALL-IN-ONE CONTAINER
K090096 · Baxter Healthcare Corporation · Jan 2009
DUAL CHAMBER TPN CONTAINER
K073538 · B.Braun Medical, Inc. · Mar 2008
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
K061197 · Kawasumi Laboratories, Inc. · Jun 2006
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004
GRI-BAG, GRI-BAG AP
K033916 · Laboratorios Grifols, S.A. · Dec 2003
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
K031419 · Laboratorios Grifols, S.A. · Nov 2003
K041038 · CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
Download PDF FDA Summary Churchill Medical Sys…