Cleared Traditional

K870395 - CHURCHILL PARENTERAL NUTRITION BAG - EVA

K870395 is an FDA 510(k) clearance for CHURCHILL PARENTERAL NUTRITION BAG - EVA, manufactured by Churchill Corp.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K870395 · Churchill Corp. · General Hospital
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Oct 1987
Decision
258d
Days
Class 2
Risk

K870395 is an FDA 510(k) clearance for the CHURCHILL PARENTERAL NUTRITION BAG - EVA. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on October 15, 1987 after a review of 258 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K870395

510(k) Number K870395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1987
Decision Date October 15, 1987
Days to Decision 258 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 129d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 116
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K870395.
BAG DECANTER
K890272 · Superior Medical Products · Mar 1989
MODIFIED EVA-MIX AND DI-MIX BAGS
K880506 · Gil-Med Industries C/O Kegan & Kegan, Ltd. · May 1988
60 ML RESERVOIR BAG, ITEM #200
K875155 · Prn Services, Inc. · Feb 1988
ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
K871449 · Pa Medical Corp. · Jun 1987
INFUMIX MIXING CONTAINER
K870052 · Biodynamics Corp. · Feb 1987
THERMAL JACKET FOR I.V. FLUID BAGS
K870113 · Thermal Medical Systems, Inc. · Feb 1987
K870395 · CHURCHILL PARENTERAL NUTRITION BAG - EVA
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