Cleared Traditional

UNIVEC NONRESUSABLE LOCKING SYRINGE (K943679) - FDA 510(k) Clearance

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

K943679 · Univec, Inc. · General Hospital
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Dec 1994
Decision
139d
Days
Class 2
Risk

K943679 is an FDA 510(k) clearance for the UNIVEC NONRESUSABLE LOCKING SYRINGE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Univec, Inc. (Garden City, US). The FDA issued a Cleared decision on December 12, 1994 after a review of 139 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Univec, Inc. devices

Submission Details

510(k) Number K943679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1994
Decision Date December 12, 1994
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 183
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K943679.
B-D ULTRA-FINE II PEN NEEDLE
K950466 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
K945809 · Sherwood Medical Co. · Mar 1995
PISTON SYRINGES
K944757 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
K943722 · Baxter Healthcare Corp · Nov 1994
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K943575 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1994
MONOJECT LUER ADAPTER
K940961 · Sherwood Medical Co. · Sep 1994