Cleared Traditional

K983994 - UNIFINE

K983994 is an FDA 510(k) clearance for UNIFINE, manufactured by Owen Mumford USA, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K983994 · Owen Mumford USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
60d
Days
Class 2
Risk

K983994 is an FDA 510(k) clearance for the UNIFINE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Owen Mumford USA, Inc. (Marietta, US). The FDA issued a Cleared decision on January 8, 1999 after a review of 60 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 Owen Mumford USA, Inc. devices

FDA 510(k) Submission Details - K983994

510(k) Number K983994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date January 08, 1999
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 530
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K983994.
EASYSAFE RETRACTING NEEDLE SYRINGE
K991039 · Saf-T-Med, Inc. · May 1999
ALLISON MEDICAL INSULIN SYRINGE (AMIS)
K984017 · Allison Medical, Inc. · Mar 1999
LITE-TOUCH SYRINGE
K983430 · Medicore, Inc. · Feb 1999
OWEN MUMFORD 3ML AUTOPEN
K983974 · Owen Mumford USA, Inc. · Dec 1998
DISETRONIC PEN
K982966 · Disetronic Medical Systems · Oct 1998
PENETREASE
K980078 · P.T. Panca Pusaka Deli · Oct 1998