Cleared Traditional

K970803 - ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE

K970803 is an FDA 510(k) clearance for ANTI-STICK SYRINGE WITH INTEGRAL HYPODE..., manufactured by Retractable Technologies, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K970803 · Retractable Technologies, Inc. · General Hospital
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May 1997
Decision
86d
Days
Class 2
Risk

K970803 is an FDA 510(k) clearance for the ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Retractable Technologies, Inc. (Little Elm, US). The FDA issued a Cleared decision on May 29, 1997 after a review of 86 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 Retractable Technologies, Inc. devices

FDA 510(k) Submission Details - K970803

510(k) Number K970803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date May 29, 1997
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 151
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K970803.
VANISHPOINT SYRINGE
K980069 · Retractable Technologies, Inc. · Feb 1998
EASYSAFE RETRACTING NEEDLE SYRINGE
K973792 · Saf-T-Med, Inc. · Jan 1998
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
K973301 · Retractable Technologies, Inc. · Nov 1997
UNIVEC NON-REUSABLE SYRINGE
K933469 · Univec, Inc. · Apr 1996
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995