Cleared Traditional

K810375 - CENTURION STOPCOCK 3 WAY

K810375 is the FDA 510(k) clearance for CENTURION STOPCOCK 3 WAY by Tri-State Hospital Supply Corp.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K810375 · Tri-State Hospital Supply Corp. · General Hospital
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Feb 1981
Decision
14d
Days
Class 2
Risk

K810375 is an FDA 510(k) clearance for the CENTURION STOPCOCK 3 WAY. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Tri-State Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1981 after a review of 14 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 Tri-State Hospital Supply Corp. devices

Submission Details

510(k) Number K810375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1981
Decision Date February 26, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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 23
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K810375.
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · Abbott Laboratories · Feb 1980
MANIFOLD, DISPOSABLE 3 VALVE
K790010 · Cordis Corp. · Feb 1979
STOPCOCK
K780596 · Abco Dealers, Inc. · Apr 1978