Cleared Traditional

UNIVEC NONREUSABLE LOCKING SYRINGE (K951619) - FDA 510(k) Clearance

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

K951619 · Univec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
71d
Days
Class 2
Risk

K951619 is an FDA 510(k) clearance for the UNIVEC NONREUSABLE LOCKING SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Univec, Inc. (Garden City, US). The FDA issued a Cleared decision on June 6, 1995 after a review of 71 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 Univec, Inc. devices

Submission Details

510(k) Number K951619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date June 06, 1995
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K951619.
B-D E ML PEN
K980755 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1998
BECTON DICKINSON SYRINGSE
K954064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995
B-D PEN ULTRA
K951919 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
MONOJECT(R) PISTON SYRINGES
K945715 · Sherwood Medical Co. · Mar 1995
SYRINGE
K942615 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1994
MEDSAVER SYRINGE
K941095 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994