Cleared Traditional

K854348 - CHURCHILL 3-WAY STOPCOCK SET

K854348 is the FDA 510(k) clearance for CHURCHILL 3-WAY STOPCOCK SET by Churchill Corp.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K854348 · Churchill Corp. · General Hospital
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Nov 1985
Decision
10d
Days
Class 2
Risk

K854348 is an FDA 510(k) clearance for the CHURCHILL 3-WAY STOPCOCK SET. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on November 8, 1985 after a review of 10 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 K854348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date November 08, 1985
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 38
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K854348.
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
CHURCHILL 3-WAY STOPCOCK
K864440 · Churchill Corp. · Jan 1987
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · Icu Medical, Inc. · Aug 1985
STOPCOCKS & EXTENSION TUBES
K840394 · American Pharmaseal Div. Ahsc · Mar 1984
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983