Cleared Traditional

EASYSAFE RETRACTING NEEDLE SYRINGE (K973792) - FDA 510(k) Clearance

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

K973792 · Saf-T-Med, Inc. · General Hospital
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Jan 1998
Decision
115d
Days
Class 2
Risk

K973792 is an FDA 510(k) clearance for the EASYSAFE RETRACTING NEEDLE SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Saf-T-Med, Inc. (Barrington, US). The FDA issued a Cleared decision on January 29, 1998 after a review of 115 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 Saf-T-Med, Inc. devices

Submission Details

510(k) Number K973792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date January 29, 1998
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K973792.
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
BECTON DICKINSON SYRINGE
K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1999
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995