Cleared Special

K060231 - CLOSED SWABABLE STOPCOCK AND MINIMAL RE...

K060231 is an FDA 510(k) clearance for CLOSED SWABABLE STOPCOCK AND MINIMAL RE..., manufactured by Elcam Medical Acal. The device is a Class 2 General Hospital device with product code FMG cleared through the Special 510(k) pathway after a 73-day FDA review.

K060231 · Elcam Medical Acal · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
73d
Days
Class 2
Risk

K060231 is an FDA 510(k) clearance for the CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-.... Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on April 13, 2006 after a review of 73 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Elcam Medical Acal devices

FDA 510(k) Submission Details - K060231

510(k) Number K060231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2006
Decision Date April 13, 2006
Days to Decision 73 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K060231.
DUAL SYRINGE HOLDER
K082110 · Surgin Surgical Instrumentation, Inc. · Jun 2009
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · Icu Medical, Inc. · Feb 2009
CLAVE STOPCOCK
K080077 · Icu Medical, Inc. · Feb 2008
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K041779 · Nipro Medical Corp. · Sep 2004
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