Cleared Traditional

K123084 - DISPOSABLE HIGH PRESSURE STOPCOCK/MANIF...

K123084 is an FDA 510(k) clearance for DISPOSABLE HIGH PRESSURE STOPCOCK/MANIF..., 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 234-day FDA review.

K123084 · Elcam Medical Acal · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
234d
Days
Class 2
Risk

K123084 is an FDA 510(k) clearance for the DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP.... 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 May 23, 2013 after a review of 234 days - an extended review 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: 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 Elcam Medical Acal devices

FDA 510(k) Submission Details - K123084

510(k) Number K123084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date May 23, 2013
Days to Decision 234 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
105d slower than avg
Panel avg: 129d · This submission: 234d
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 42
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K123084.
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
K190539 · Monumedical, LLC · Oct 2019
Elcam Stopcocks and Manifolds
K190489 · Elcam Medical Acal · Apr 2019
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
DUAL SYRINGE HOLDER
K082110 · Surgin Surgical Instrumentation, Inc. · Jun 2009
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · Icu Medical, Inc. · Feb 2009