Cleared Traditional

K032393 - INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)

K032393 is an FDA 510(k) clearance for INDUCTION AND SAMPLING MANIFOLD (OR STO..., manufactured by Elcam Medical Acal. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K032393 · Elcam Medical Acal · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
39d
Days
Class 2
Risk

K032393 is an FDA 510(k) clearance for the INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK). Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Elcam Medical Acal (Phoenix, US). The FDA issued a Cleared decision on September 12, 2003 after a review of 39 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 Elcam Medical Acal devices

FDA 510(k) Submission Details - K032393

510(k) Number K032393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date September 12, 2003
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 60
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K032393.
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
K060231 · Elcam Medical Acal · Apr 2006
TRU-SWAB STOCOCK
K052330 · Medegen Medical Manufacturing Services · Sep 2005
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K041779 · Nipro Medical Corp. · Sep 2004
ELCAM STOPCOCKS AND MANIFOLDS
K022895 · Medical Device Consultants, Inc. · Oct 2002
CHURCHILL MEDICAL SYSTEMS STOPCOCK
K012157 · Churchill Medical Systems, Inc. · Sep 2001
4 PORT, 4 WAY STOPCOCK
K010217 · George Loo, MD · Mar 2001