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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K050134.
UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
K050116 · Uniqsafe Biomeditech Co., Ltd. · May 2005
P&P SAFETY SYRINGE
K043419 · Medexel Medical Mfg. Co., Ltd. · Apr 2005
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
K050131 · M.K. Meditech Co. , Ltd. · Apr 2005
YIXIN SAFETY SYRINGE
K042102 · Jiangxi Sanxin (Eversincere) Medical Devices Group · Mar 2005
PROCEDUR SF SAFETY SYRINGE DEVICE
K042487 · Avanca Medical Devices, Inc. · Jan 2005
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
K043038 · Biotop Technology Co., Ltd. · Dec 2004
K050134 · ICC INSULIN SAFEPRO SAFETY SYRINGE
Download PDF FDA Summary Formosa Medical Devic…