Cleared Abbreviated

K062780 - CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE

K062780 is an FDA 510(k) clearance for CLICKZIP, manufactured by Medical Device Manufacturer (Thailand) , Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 109-day FDA review.

K062780 · Medical Device Manufacturer (Thailand) , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
109d
Days
Class 2
Risk

K062780 is an FDA 510(k) clearance for the CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Medical Device Manufacturer (Thailand) , Ltd. (Rayong, TH). The FDA issued a Cleared decision on January 5, 2007 after a review of 109 days - within the typical 510(k) review window.

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 - K062780

510(k) Number K062780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date January 05, 2007
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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 K062780.
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
K070203 · Inviro Medical Devices, Inc. · Apr 2007
SAF-T-SYRINGE- 0.5 AND 1ML/CC
K063340 · Safety Medical International, Incorporated · Mar 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
K062318 · Biotop Technology Co., Ltd. · Jan 2007
OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
K060971 · Omi Manufacturing Pty., Ltd. · Oct 2006
MANUEL SAFTEY SYRINGE PARTS 1 & 2
K060772 · Medsafe Asa · Oct 2006
K062780 · CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
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