Cleared Special

K141359 - HARD PACK SYRINGE

K141359 is the FDA 510(k) clearance for HARD PACK SYRINGE by Jiangyin Caina Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 63-day FDA review.

K141359 · Jiangyin Caina Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
63d
Days
Class 2
Risk

K141359 is an FDA 510(k) clearance for the HARD PACK SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangyin Caina Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 25, 2014 after a review of 63 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jiangyin Caina Technology Co., Ltd. devices

Submission Details

510(k) Number K141359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2014
Decision Date July 25, 2014
Days to Decision 63 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K141359.
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
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