Cleared Traditional

K080077 - CLAVE STOPCOCK

K080077 is the FDA 510(k) clearance for CLAVE STOPCOCK by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K080077 · Icu Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
33d
Days
Class 2
Risk

K080077 is an FDA 510(k) clearance for the CLAVE STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 13, 2008 after a review of 33 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K080077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2008
Decision Date February 13, 2008
Days to Decision 33 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 129d · This submission: 33d
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 35
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K080077.
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
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · Icu Medical, Inc. · Feb 2009
MANIFOLD WITH EXTENSION SET
K982368 · Interpore Cross Intl. · Jul 1998
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083 · Ohmeda Medical · Jan 1998
PRIMARY IV SET
K964435 · Icu Medical, Inc. · Apr 1997