Cleared Traditional

K950666 - UNIQUE NEEDLE WITH FIRM GRIP SHIELD

K950666 is an FDA 510(k) clearance for UNIQUE NEEDLE WITH FIRM GRIP SHIELD, manufactured by Unique Management Ent., Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K950666 · Unique Management Ent., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
368d
Days
Class 2
Risk

K950666 is an FDA 510(k) clearance for the UNIQUE NEEDLE WITH FIRM GRIP SHIELD. 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 February 16, 1996 after a review of 368 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

FDA 510(k) Submission Details - K950666

510(k) Number K950666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date February 16, 1996
Days to Decision 368 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 129d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 417
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K950666.
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
K955282 · Thermogenesis Corp. · May 1996
GENERAL PROCEDURE KIT
K960248 · Physician Industries, Inc. · Apr 1996
S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
K955164 · Habley Medical Technology Corp. · Mar 1996
BECTON DICKINSON SYRINGSE
K954064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995
GENOTROPIN MIXER
K954337 · Pharmacia, Inc. · Nov 1995
B-D PEN ULTRA
K951919 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995