Cleared Traditional

K083686 - BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES

K083686 is an FDA 510(k) clearance for BAIXIN DISPOSABLE SYRINGE, manufactured by Anhui Kangda Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K083686 · Anhui Kangda Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
202d
Days
Class 2
Risk

K083686 is an FDA 510(k) clearance for the BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Anhui Kangda Medical Products Co., Ltd. (Pudong, Shanghai, CN). The FDA issued a Cleared decision on July 2, 2009 after a review of 202 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 Anhui Kangda Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K083686

510(k) Number K083686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2008
Decision Date July 02, 2009
Days to Decision 202 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
73d slower than avg
Panel avg: 129d · This submission: 202d
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 375
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K083686.
COAXIAL APPLICATOR SYSTEM
K091722 · Biomet, Inc. · Mar 2010
ACACIA PISTON SYRINGE
K092986 · Acacia, Inc. · Oct 2009
NIPRO DISPOSABLE SYRINGE
K091279 · Nipro Medical Corporation · Aug 2009
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