Cleared Traditional

K011951 - EZ SYRINGE

K011951 is an FDA 510(k) clearance for EZ SYRINGE, manufactured by Owen Mumford, Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K011951 · Owen Mumford, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
42d
Days
Class 2
Risk

K011951 is an FDA 510(k) clearance for the EZ SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Owen Mumford, Ltd. (Marietta, US). The FDA issued a Cleared decision on August 2, 2001 after a review of 42 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, Ltd. devices

FDA 510(k) Submission Details - K011951

510(k) Number K011951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date August 02, 2001
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K011951.
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147 · Medtronic Perfusion Systems · Apr 2002
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868 · Micromedics, Inc. · Oct 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · Orthovita, Inc. · Sep 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · Interpore Cross Intl. · Apr 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · Terumo Medical Corp. · Feb 2001
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001