Cleared Traditional

K142435 - 3S Safety Syringe with/without Needle

K142435 is an FDA 510(k) clearance for 3S Safety Syringe with/without Needle, manufactured by Sincere Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K142435 · Sincere Medical Device Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
175d
Days
Class 2
Risk

K142435 is an FDA 510(k) clearance for the 3S Safety Syringe with/without Needle. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Sincere Medical Device Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on February 20, 2015 after a review of 175 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K142435

510(k) Number K142435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2014
Decision Date February 20, 2015
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 K142435.
Disposable Safety Self-destructive Syringes, 5 ML
K143070 · Jiangsu Yile Medical Article Co., Ltd. · Jul 2015
Safe'n'Sound Staked Passive Delivery System - Plajex version
K150562 · Nemera · Jun 2015
Disposable sterile needle retractable safety syringe
K141349 · Guangdong Haiou Medical Apparatus Stock Co., Ltd. · Apr 2015
3S Safety Insulin Syringe
K142436 · Sincere Medical Device Co., Ltd. · Feb 2015
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
K140949 · Ultimed Incorporated · Feb 2015
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
K141640 · Shantou Wealy Medical Instrument Co.,Ltd · Nov 2014
K142435 · 3S Safety Syringe with/without Needle
Download PDF FDA Summary Sincere Medical Devic…