Cleared Traditional

K880027 - CHURCHILL 1.2 MICRON LIQUID FILTER SET

K880027 is an FDA 510(k) clearance for CHURCHILL 1.2 MICRON LIQUID FILTER SET, manufactured by Churchill Corp.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K880027

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.

FPB Device Classification - Class 2, Special Controls

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 72
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