Cleared Traditional

K872124 - CHURCHILL ALBUMIN IV ADMINISTRATION SET

K872124 is the FDA 510(k) clearance for CHURCHILL ALBUMIN IV ADMINISTRATION SET by Churchill Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K872124 · Churchill Corp. · General Hospital
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Oct 1987
Decision
134d
Days
Class 2
Risk

K872124 is an FDA 510(k) clearance for the CHURCHILL ALBUMIN IV ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on October 13, 1987 after a review of 134 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 K872124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date October 13, 1987
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 464
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K872124.
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PHARMACIA DELTEC BAG SPIKE SET
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CHURCHILL TPN ADMINISTRATION SET
K872123 · Churchill Corp. · Oct 1987
CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
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THE GRIPPER(TM) PORT-A-CATH NEEDLES
K870866 · Pharmacia, Inc. · Jun 1987