Cleared Abbreviated

K133493 - SINGLE USE STERILE SYRINGE WITH NEEDLE

K133493 is an FDA 510(k) clearance for SINGLE USE STERILE SYRINGE WITH NEEDLE, manufactured by Jiangxi Kelun Medical Devices Manufacturing Co.,Lt. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 133-day FDA review.

K133493 · Jiangxi Kelun Medical Devices Manufacturing Co.,Lt · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
133d
Days
Class 2
Risk

K133493 is an FDA 510(k) clearance for the SINGLE USE STERILE SYRINGE WITH NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangxi Kelun Medical Devices Manufacturing Co.,Lt (Wenzhou, Zhejiang, CN). The FDA issued a Cleared decision on March 27, 2014 after a review of 133 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.

View all Jiangxi Kelun Medical Devices Manufacturing Co.,Lt devices

FDA 510(k) Submission Details - K133493

510(k) Number K133493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2013
Decision Date March 27, 2014
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Standards-based clearance path.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 343
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K133493.
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014
NAMIC RCS SYRINGE
K140194 · Navilyst Medical, Inc. · Apr 2014
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641 · Nipro Medical Corporation · Aug 2013
MONOJECT 12ML SYRINGE
K130049 · Nipro Medical Corporation · Feb 2013
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · Becton, Dickinson and Company · May 2012