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)
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.

View all Shan Dong Wei Gao Group Medical Polymer Products devices

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
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 11
Devices cleared under the same product code (BRZ) and FDA review panel - the closest regulatory comparables to K083349.
Blood Administration Sets
K220558 · Baxter Healthcare Corporation · Nov 2022
Blood Administration Set
K210335 · Baxter Healthcare Corporation · Jun 2021
MODIFIED BLOOD RECIPIENT SET
K993120 · Baxter Healthcare Corp · Nov 1999
PROTOS BLOOD TRANSFUSION SET
K972843 · Globe Ent., Inc. · Dec 1997
Y-TYPE BLOOD ADMINISTRATION SET
K940074 · Puritas Health Care, Inc. · Apr 1994
MULTISET
K940055 · Puritas Health Care, Inc. · Apr 1994