Cleared Traditional

K911415 - TRUMPET VALVE

K911415 is an FDA 510(k) clearance for TRUMPET VALVE, manufactured by B. Braun of America, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K911415 · B. Braun of America, Inc. · General Hospital
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Jun 1991
Decision
63d
Days
Class 2
Risk

K911415 is an FDA 510(k) clearance for the TRUMPET VALVE. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 63 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 B. Braun of America, Inc. devices

FDA 510(k) Submission Details - K911415

510(k) Number K911415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date June 03, 1991
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 40
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K911415.
STOPCOCK & LUER LOCK PLUG
K954970 · Medex, Inc. · Apr 1996
ICU STOPCOK WITH EXTENSION TUBING
K953573 · Icu Medical, Inc. · Oct 1995
MULTI-PORT MANIFOLD
K932512 · Baxter Healthcare Corp · Feb 1994
ADVANCE DISPOSABLE STOPCOCK
K902724 · Advance Medical Designs, Inc. · Dec 1990
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989