Cleared Traditional

K913560 - STOPCOCK

K913560 is an FDA 510(k) clearance for STOPCOCK, manufactured by Graham Medical Products. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K913560 · Graham Medical Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
144d
Days
Class 2
Risk

K913560 is an FDA 510(k) clearance for the STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Graham Medical Products (Holyoke, US). The FDA issued a Cleared decision on December 31, 1991 after a review of 144 days - within the typical 510(k) review window.

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 Graham Medical Products devices

FDA 510(k) Submission Details - K913560

510(k) Number K913560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1991
Decision Date December 31, 1991
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
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 58
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K913560.
ICU STOPCOK WITH EXTENSION TUBING
K953573 · Icu Medical, Inc. · Oct 1995
STOPCOCK INTRAVENOUS THERAPY
K940070 · Puritas Health Care, Inc. · Apr 1994
MULTI-PORT MANIFOLD
K932512 · Baxter Healthcare Corp · Feb 1994
TRUMPET VALVE
K911415 · B. Braun of America, Inc. · Jun 1991
ADVANCE DISPOSABLE STOPCOCK
K902724 · Advance Medical Designs, Inc. · Dec 1990
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989