Cleared Traditional

K082110 - DUAL SYRINGE HOLDER

K082110 is an FDA 510(k) clearance for DUAL SYRINGE HOLDER, manufactured by Surgin Surgical Instrumentation, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K082110 · Surgin Surgical Instrumentation, Inc. · General Hospital
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Jun 2009
Decision
324d
Days
Class 2
Risk

K082110 is an FDA 510(k) clearance for the DUAL SYRINGE HOLDER. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Surgin Surgical Instrumentation, Inc. (Irvine, US). The FDA issued a Cleared decision on June 17, 2009 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Surgin Surgical Instrumentation, Inc. devices

FDA 510(k) Submission Details - K082110

510(k) Number K082110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date June 17, 2009
Days to Decision 324 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 129d · This submission: 324d
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 41
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K082110.
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
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