Cleared Traditional

K124037 - JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE

K124037 is an FDA 510(k) clearance for JUNG RIM SINGLE USE HYPODERMIC SYRINGE ..., manufactured by Jung Rim Medical Industrial Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K124037 · Jung Rim Medical Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
258d
Days
Class 2
Risk

K124037 is an FDA 510(k) clearance for the JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jung Rim Medical Industrial Co., Ltd. (Jincheon-Gun, Chungbuk, KR). The FDA issued a Cleared decision on September 12, 2013 after a review of 258 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 - K124037

510(k) Number K124037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2012
Decision Date September 12, 2013
Days to Decision 258 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
129d slower than avg
Panel avg: 129d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 620
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K124037.
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
K130230 · Wuxi Yushou Medical Applicances Co., Ltd. · Nov 2013
INFUSION SYRINGE SET
K131661 · Innovative Medical Manufacturing Co. · Nov 2013
TAUTONA INJECTOR DEVICE
K131963 · Tautona Group, LLC · Oct 2013
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641 · Nipro Medical Corporation · Aug 2013
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
K123766 · Novo Nordisk, Inc. · Aug 2013
EVICEL APPLICATION DEVICE
K130900 · Ethicon Inc (On Behalf of Omrix Biopharaceuticals · Aug 2013
K124037 · JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
Download PDF FDA Summary Jung Rim Medical Indu…