Cleared Traditional

K210335 - Blood Administration Set

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

K210335 · Baxter Healthcare Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K210335

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.

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 14
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
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
K132905 · Arteriocyte Medical Systems, Inc. · Oct 2013
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
BLOOD HAND PUMP ADMINISTRATION SET
K050115 · Cardinal Health, Alaris Products · Apr 2005
MODIFIED BLOOD RECIPIENT SET
K993120 · Baxter Healthcare Corp · Nov 1999