Cleared Traditional

K210335 - Blood Administration Set

K210335 is the FDA 510(k) clearance for Blood Administration Set by Baxter Healthcare Corporation. It is a Class 2 General Hospital device (product code BRZ) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K210335 · Baxter Healthcare Corporation · General Hospital
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Jun 2021
Decision
125d
Days
Class 2
Risk

K210335 is an FDA 510(k) clearance for the Blood Administration Set. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on June 10, 2021 after a review of 125 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 Baxter Healthcare Corporation devices

Submission Details

510(k) Number K210335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2021
Decision Date June 10, 2021
Days to Decision 125 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
4d faster than avg
Panel avg: 129d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (BRZ) and FDA review panel - the closest regulatory comparables to K210335.
Blood Administration Sets
K220558 · Baxter Healthcare Corporation · Nov 2022
MODIFIED BLOOD RECIPIENT SET
K993120 · Baxter Healthcare Corp · Nov 1999
IV ADMINISTRATION SET
K871908 · Travenol Laboratories, S.A. · Jul 1987
CHURCHILL BLOOD ADMINISTRATION SET
K864441 · Churchill Corp. · Jan 1987
VYGON EXCHANGE TRANSFUSION TRAY 275.00
K851477 · Vygon Corp. · May 1985