Cleared Traditional

K001017 - RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC

K001017 is an FDA 510(k) clearance for RETRAX RETRACTING NEEDLE SYRINGE, manufactured by Retrax Safety Systems, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K001017 · Retrax Safety Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
65d
Days
Class 2
Risk

K001017 is an FDA 510(k) clearance for the RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Retrax Safety Systems, Inc. (Miami, US). The FDA issued a Cleared decision on June 2, 2000 after a review of 65 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 Retrax Safety Systems, Inc. devices

FDA 510(k) Submission Details - K001017

510(k) Number K001017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date June 02, 2000
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 96
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K001017.
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
K041970 · Biotop Technology Co., Ltd. · Aug 2004
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000
SUPERGUARD SAFETY SYRINGE
K990831 · U.S. Safety Syringes Co., Inc. · Mar 2000
BECTON DICKINSON SYRINGE
K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1999