Cleared Traditional

K132905 - 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER

K132905 is an FDA 510(k) clearance for 200 MICRON BLOOD COMPONENT FILTER AND S..., manufactured by Arteriocyte Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code BRZ cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K132905 · Arteriocyte Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
18d
Days
Class 2
Risk

K132905 is an FDA 510(k) clearance for the 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Arteriocyte Medical Systems, Inc. (Hopkinton, US). The FDA issued a Cleared decision on October 4, 2013 after a review of 18 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arteriocyte Medical Systems, Inc. devices

FDA 510(k) Submission Details - K132905

510(k) Number K132905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date October 04, 2013
Days to Decision 18 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Pharmalink Technical Group, LLC
DAVID YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K132905.
Blood Administration Sets
K220558 · Baxter Healthcare Corporation · Nov 2022
Blood Administration Set
K210335 · Baxter Healthcare Corporation · Jun 2021
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

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.