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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 638
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K083686.
NIPRO DISPOSABLE SYRINGE
K091279 · Nipro Medical Corporation · Aug 2009
SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES
K091167 · Shina Corp. · Aug 2009
EASY.TOUCH INSULIN SYRINGE
K091474 · Masters Healthcare, LLC · Jul 2009
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
XPRESSE INJECTION SYSTEM
K083583 · Nordson Efd · Jun 2009
STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
K090929 · Shanghai Double Dove Industrial Co., Ltd. · Jun 2009
K083686 · BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
Download PDF FDA Summary Anhui Kangda Medical …