Cleared Traditional

K083193 - REVAC AUTO RETRACTABLE SAFETY SYRINGE

K083193 is an FDA 510(k) clearance for REVAC AUTO RETRACTABLE SAFETY SYRINGE, manufactured by Revolutions Medical Corporation, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K083193 · Revolutions Medical Corporation, Inc. · General Hospital
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Feb 2009
Decision
107d
Days
Class 2
Risk

K083193 is an FDA 510(k) clearance for the REVAC AUTO RETRACTABLE SAFETY SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Revolutions Medical Corporation, Inc. (Charleston, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 107 days - within the typical 510(k) review window.

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: 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 Revolutions Medical Corporation, Inc. devices

FDA 510(k) Submission Details - K083193

510(k) Number K083193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2008
Decision Date February 13, 2009
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 379
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K083193.
NIPRO DISPOSABLE SYRINGE
K091279 · Nipro Medical Corporation · Aug 2009
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · Terumo Europe N.V. · May 2009
MICROMYST APPLICATOR, MODEL 20-5000
K082454 · Covidien · Nov 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007