Cleared Traditional

BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES (K083686) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083686 · Anhui Kangda Medical Products Co., Ltd. · General Hospital
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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

Submission Details

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.

Device Classification

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.

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All 749
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