Cleared Traditional

K072739 - JIERUI SYRINGES AND NEEDLES

K072739 is an FDA 510(k) clearance for JIERUI SYRINGES AND NEEDLES, manufactured by Shandong Weigao Group Medical Polymer Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K072739 · Shandong Weigao Group Medical Polymer Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
176d
Days
Class 2
Risk

K072739 is an FDA 510(k) clearance for the JIERUI SYRINGES AND NEEDLES. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Shandong Weigao Group Medical Polymer Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 21, 2008 after a review of 176 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.

View all Shandong Weigao Group Medical Polymer Co., Ltd. devices

FDA 510(k) Submission Details - K072739

510(k) Number K072739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date March 21, 2008
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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 149
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K072739.
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
K092430 · Inviro Medical Devices, Inc. · Sep 2009
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
K080877 · Unilife Medical Solutions Limited · Oct 2008
ULTIMED ULTICARE SAFETY SYRINGE
K080600 · Ultimed, Inc. · Jun 2008
NEEDLE-TRAP/NEEDLE SAFETY LABEL
K073206 · Schreiner Medipharm · Jan 2008
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
K072037 · Life-Shield Products, Inc. · Aug 2007