Cleared Abbreviated

K050134 - ICC INSULIN SAFEPRO SAFETY SYRINGE

K050134 is an FDA 510(k) clearance for ICC INSULIN SAFEPRO SAFETY SYRINGE, manufactured by Formosa Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 74-day FDA review.

K050134 · Formosa Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
74d
Days
Class 2
Risk

K050134 is an FDA 510(k) clearance for the ICC INSULIN SAFEPRO SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Formosa Medical Devices, Inc. (Taipei, TW). The FDA issued a Cleared decision on April 5, 2005 after a review of 74 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Formosa Medical Devices, Inc. devices

FDA 510(k) Submission Details - K050134

510(k) Number K050134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2005
Decision Date April 05, 2005
Days to Decision 74 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 129d · This submission: 74d
Pathway characteristics
Standards-based clearance path.

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 62
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K050134.
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
K061194 · Smiths Medical Asd, Inc. · Aug 2006
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000