Cleared Traditional

K003348 - E.N.S.I. RETRACTABLE SAFETY SYRINGE

K003348 is an FDA 510(k) clearance for E.N.S.I. RETRACTABLE SAFETY SYRINGE, manufactured by Ensi-Med International Pty. , Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K003348 · Ensi-Med International Pty. , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
78d
Days
Class 2
Risk

K003348 is an FDA 510(k) clearance for the E.N.S.I. RETRACTABLE SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Ensi-Med International Pty. , Ltd. (Seaford, Victoria, AU). The FDA issued a Cleared decision on January 12, 2001 after a review of 78 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.

FDA 510(k) Submission Details - K003348

510(k) Number K003348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2000
Decision Date January 12, 2001
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K003348.
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
K003555 · Spectrum Biotech, Inc. · Aug 2001
BD SPRING BASED SYRINGE
K011103 · Bd · Jun 2001
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
K011369 · Safety Syringes, Inc. · May 2001
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
FUTURA SAFETY SYRINGE
K000860 · Sheila W. Pickering · Jun 2000
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
K001017 · Retrax Safety Systems, Inc. · Jun 2000
K003348 · E.N.S.I. RETRACTABLE SAFETY SYRINGE
Download PDF FDA Summary Ensi-Med Internationa…