Cleared Traditional

TRI-FLOW THREE WAY STOPCOCK (K961982) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961982 · North, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
277d
Days
Class 2
Risk

K961982 is an FDA 510(k) clearance for the TRI-FLOW THREE WAY STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by North, Inc. (Northfield, US). The FDA issued a Cleared decision on February 21, 1997 after a review of 277 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 North, Inc. devices

Submission Details

510(k) Number K961982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date February 21, 1997
Days to Decision 277 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 129d · This submission: 277d
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 16
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K961982.
Elcam Stopcocks and Manifolds
K190489 · Elcam Medical Acal · Apr 2019
Dynarex Three-Way Stopcock
K172266 · Dynarex Corporation · Mar 2018
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
K130245 · Baxter Healthcare Corp · Mar 2013
STOPCOCK MANIFOLD GANGS
K962581 · Baxter Healthcare Corp · Aug 1996
MULTI-PORT MANIFOLD
K932512 · Baxter Healthcare Corp · Feb 1994
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989