Cleared Traditional

K031394 - AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE

K031394 is an FDA 510(k) clearance for AMERICAN SYRINGE COMPANY 1CC AND 3CC SY..., manufactured by American Syringe Company. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K031394 · American Syringe Company · General Hospital
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Jul 2003
Decision
84d
Days
Class 2
Risk

K031394 is an FDA 510(k) clearance for the AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by American Syringe Company (Miami, US). The FDA issued a Cleared decision on July 25, 2003 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 American Syringe Company devices

FDA 510(k) Submission Details - K031394

510(k) Number K031394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2003
Decision Date July 25, 2003
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 446
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K031394.
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
NIPRO DISPOSABLE SYRINGES
K030683 · Nipro Medical Corp. · Oct 2003
IMBIBE II SYRINGE
K030208 · Orthovita, Inc. · Apr 2003
IMBIBE BONE MARROW ASPIRATION SYRINGE
K023074 · Orthovita, Inc. · Mar 2003
MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003