Cleared Traditional

UNIQUE NEEDLE (K950245) - FDA 510(k) Clearance

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

K950245 · Unique Management Ent., Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
320d
Days
Class 2
Risk

K950245 is an FDA 510(k) clearance for the UNIQUE NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Unique Management Ent., Inc. (Albany, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Unique Management Ent., Inc. devices

Submission Details

510(k) Number K950245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1995
Decision Date December 06, 1995
Days to Decision 320 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
191d slower than avg
Panel avg: 129d · This submission: 320d
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 223
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K950245.
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · Terumo Medical Corp. · Apr 1998
B-D E ML PEN
K980755 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1998
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · Terumo Medical Corp. · May 1996
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
PTFE SYRINGE FILTER
K952918 · B.Braun Medical, Inc. · Sep 1995