Cleared Traditional

DUAL SYRINGE HOLDER (K082110) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 88
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K082110.
Qitexio® 4-Way Stopcock (QIT014)
K242255 · Medex · Apr 2025
Three Way Stop Cock
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lntravascular Administration Sets with Stopcock and Manifold
K223175 · Baxter Healthcare Corporation · Mar 2023
SafePort(TM) Manifold (or Stopcock)
K211204 · Elcam Medical Acal · Sep 2022
Clicky Cross
K210516 · Yomura Technologies, Inc. · May 2022
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