Cleared Traditional

K854636 - CHURCHILL-HE VENTED IV SET

K854636 is the FDA 510(k) clearance for CHURCHILL-HE VENTED IV SET by Churchill Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K854636 · Churchill Corp. · General Hospital
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Dec 1985
Decision
21d
Days
Class 2
Risk

K854636 is an FDA 510(k) clearance for the CHURCHILL-HE VENTED IV 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 December 10, 1985 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Churchill Corp. devices

Submission Details

510(k) Number K854636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date December 10, 1985
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 K854636.
CHURCHILL-HCM VENTED IV SET
K854628 · Churchill Corp. · Jan 1986
CHURCHILL-HS SUSPENDED VENTED IV SET
K854627 · Churchill Corp. · Dec 1985
CHURCHILL-HS SUSPENDED NON-VENTED IV SET
K854630 · Churchill Corp. · Dec 1985
CHURCHILL-H NON-VENTED IV SET
K854435 · Churchill Corp. · Dec 1985
CHURCHILL-H SCALP VEIN SET
K854436 · Churchill Corp. · Dec 1985
CHURCHILL-H VENTED IV SET
K854437 · Churchill Corp. · Dec 1985