Cleared Abbreviated

K032517 - MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE

K032517 is an FDA 510(k) clearance for MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRI..., manufactured by Medsafe Technologies, LLC. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 278-day FDA review.

K032517 · Medsafe Technologies, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
278d
Days
Class 2
Risk

K032517 is an FDA 510(k) clearance for the MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Medsafe Technologies, LLC (Alpharetta, US). The FDA issued a Cleared decision on May 18, 2004 after a review of 278 days - an extended review 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 - K032517

510(k) Number K032517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2003
Decision Date May 18, 2004
Days to Decision 278 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
149d slower than avg
Panel avg: 129d · This submission: 278d
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 K032517.
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · Safety Syringes, Inc. · Oct 2004
TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
K042426 · Taiject Medical Device Co., Ltd. · Sep 2004
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
K041970 · Biotop Technology Co., Ltd. · Aug 2004
BIOTOP DJT-A SAFETY SYRINGE
K032747 · Biotop Technology Co., Ltd. · May 2004
PERFECT SAFETY SYRINGE
K030604 · Perfect Medical Industry Co., Ltd. · Apr 2004
OTTER SAFETY SYRINGE
K040545 · Otter (China) Technology Co., Ltd. · Apr 2004
K032517 · MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE
Download PDF FDA Summary Medsafe Technologies,…