Cleared Traditional

K993996 - UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE

K993996 is an FDA 510(k) clearance for UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE, manufactured by Univec, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K993996 · Univec, Inc. · General Hospital
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Jul 2000
Decision
236d
Days
Class 2
Risk

K993996 is an FDA 510(k) clearance for the UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Univec, Inc. (Farmingdale, US). The FDA issued a Cleared decision on July 17, 2000 after a review of 236 days - an extended review 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: 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.

FDA 510(k) Submission Details - K993996

510(k) Number K993996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date July 17, 2000
Days to Decision 236 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
107d slower than avg
Panel avg: 129d · This submission: 236d
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K993996.
BD SPRING BASED SYRINGE
K011103 · Bd · Jun 2001
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
K011369 · Safety Syringes, Inc. · May 2001
E.N.S.I. RETRACTABLE SAFETY SYRINGE
K003348 · Ensi-Med International Pty. , Ltd. · Jan 2001
FUTURA SAFETY SYRINGE
K000860 · Sheila W. Pickering · Jun 2000
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
K001017 · Retrax Safety Systems, Inc. · Jun 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000
K993996 · UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
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