Cleared Traditional

K083349 - BLOOD TRANSFUSION SET

K083349 is an FDA 510(k) clearance for BLOOD TRANSFUSION SET, manufactured by Shan Dong Wei Gao Group Medical Polymer Products. The device is a Class 2 General Hospital device with product code BRZ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K083349 · Shan Dong Wei Gao Group Medical Polymer Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
148d
Days
Class 2
Risk

K083349 is an FDA 510(k) clearance for the BLOOD TRANSFUSION SET. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Shan Dong Wei Gao Group Medical Polymer Products (Shan Nan Er Rd., Shanghai, CN). The FDA issued a Cleared decision on April 10, 2009 after a review of 148 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 - K083349

510(k) Number K083349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2008
Decision Date April 10, 2009
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BRZ Device Classification - Class 2, Special Controls

Product Code BRZ Set, Blood Transfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - BRZ Set, Blood Transfusion

All 21
Devices cleared under the same product code (BRZ) and FDA review panel - the closest regulatory comparables to K083349.
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K220558 · Baxter Healthcare Corporation · Nov 2022
Blood Administration Set
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K132905 · Arteriocyte Medical Systems, Inc. · Oct 2013
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
K073339 · Fenwal, Inc. · Mar 2008
PENTATRASFU BLOOD TRANSFUSION SETS
K041496 · Pentaferte S.P.A · Jun 2005
30 ML OR 60 ML PEDI-SYRINGE FILTER
K050805 · Blood Products Specialties, LLC · Jun 2005
K083349 · BLOOD TRANSFUSION SET
Download PDF FDA Summary Shan Dong Wei Gao Gro…