Cleared Traditional

K891234 - TERUFUSION THREE WAY STOPCOCK

K891234 is an FDA 510(k) clearance for TERUFUSION THREE WAY STOPCOCK, manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K891234 · Terumo Medical Corp. · General Hospital
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Sep 1989
Decision
196d
Days
Class 2
Risk

K891234 is an FDA 510(k) clearance for the TERUFUSION THREE WAY STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on September 19, 1989 after a review of 196 days - an extended review 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: 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K891234

510(k) Number K891234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date September 19, 1989
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMG Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K891234.
STOPCOCK INTRAVENOUS THERAPY
K940070 · Puritas Health Care, Inc. · Apr 1994
MULTI-PORT MANIFOLD
K932512 · Baxter Healthcare Corp · Feb 1994
ADVANCE DISPOSABLE STOPCOCK
K902724 · Advance Medical Designs, Inc. · Dec 1990
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987