Cleared Traditional

K854628 - CHURCHILL-HCM VENTED IV SET

K854628 is an FDA 510(k) clearance for CHURCHILL-HCM VENTED IV SET, manufactured by Churchill Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K854628 · Churchill Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
52d
Days
Class 2
Risk

K854628 is an FDA 510(k) clearance for the CHURCHILL-HCM 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 January 9, 1986 after a review of 52 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

FDA 510(k) Submission Details - K854628

510(k) Number K854628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date January 09, 1986
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K854628.
CHURCHILL - HBC VENTED BALL CHECK IV SET
K854658 · Churchill Corp. · Jan 1986
IVAC CONTROLLED RELEASE INFUSION SYSTEM
K854574 · Y · Jan 1986
TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
K854446 · Terumo Medical 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-HE VENTED IV SET
K854636 · Churchill Corp. · Dec 1985