Cleared Traditional

K870395 - CHURCHILL PARENTERAL NUTRITION BAG - EVA

K870395 is the FDA 510(k) clearance for CHURCHILL PARENTERAL NUTRITION BAG - EVA by Churchill Corp.. It is a Class 2 General Hospital device (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.

View all Churchill Corp. devices

Submission Details

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.

Device Classification

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 34
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K870395.
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · Baxter Healthcare Corp · Jun 1994
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
NUTRIMIX EMPTY CONTAINER
K860042 · Abbott Laboratories · Apr 1986
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983