Cleared Traditional

K081241 - WEIGAO EMPTY CARTRIDGE SYRINGE

K081241 is an FDA 510(k) clearance for WEIGAO EMPTY CARTRIDGE SYRINGE, manufactured by Shandong Weigao Group Medical Polymer Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K081241 · Shandong Weigao Group Medical Polymer Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
130d
Days
Class 2
Risk

K081241 is an FDA 510(k) clearance for the WEIGAO EMPTY CARTRIDGE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shandong Weigao Group Medical Polymer Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 8, 2008 after a review of 130 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 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 - K081241

510(k) Number K081241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2008
Decision Date September 08, 2008
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
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 331
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K081241.
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · Terumo Europe N.V. · May 2009
MICROMYST APPLICATOR, MODEL 20-5000
K082454 · Covidien · Nov 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007