Cleared Special

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (K082106) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082106 · Elcam Medical Acal · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
69d
Days
Class 2
Risk

K082106 is an FDA 510(k) clearance for the ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS). 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 October 2, 2008 after a review of 69 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

Submission Details

510(k) Number K082106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2008
Decision Date October 02, 2008
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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 21
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K082106.
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
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083 · Ohmeda Medical · Jan 1998
STOPCOCK MANIFOLD GANGS
K962581 · Baxter Healthcare Corp · Aug 1996
MULTI-PORT MANIFOLD
K932512 · Baxter Healthcare Corp · Feb 1994