Cleared Traditional

K880027 - CHURCHILL 1.2 MICRON LIQUID FILTER SET

K880027 is the FDA 510(k) clearance for CHURCHILL 1.2 MICRON LIQUID FILTER SET by Churchill Corp.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K880027 · Churchill Corp. · General Hospital
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Apr 1988
Decision
99d
Days
Class 2
Risk

K880027 is an FDA 510(k) clearance for the CHURCHILL 1.2 MICRON LIQUID FILTER SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 K880027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date April 13, 1988
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPB Filter, Infusion Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPB Filter, Infusion Line

All 41
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K880027.
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · Miles Laboratories, Inc. · May 1988
CHURCHILL 0.22 MICRON LIQUID FILTER SETS
K880025 · Churchill Corp. · Apr 1988
CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS
K880026 · Churchill Corp. · Apr 1988
CUTTER PUREFLO PLUS IV FILTER
K872634 · Miles Laboratories, Inc. · Aug 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · Travenol Laboratories, S.A. · Apr 1987
CRITIKON 48-HOUR AIR ELIMINATING FILTER
K861644 · Critikon Company, LLC · Jul 1986