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30 Ml or 60 Ml Pedi-Syringe Filter

by Blood Products Specialties, LLC 510(k)

Active United States

510(k) K050805

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050805 Date20 Jun 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2669-2014 FDA Class II initiated 17 Jul 2014
    • Terminated Z-2667-2014 FDA Class II initiated 17 Jul 2014
    • Terminated Z-2668-2014 FDA Class II initiated 17 Jul 2014

    Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

Specification

510(k)

510(k) Number
FDA Product Code
BRZ
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a set for blood transfusion, specifically a pediatric syringe filter available in 30 mL or 60 mL volumes. It is designed to filter blood or blood components during transfusion procedures.

The device is supplied sterile and intended for single-use. It has received FDA 510(k) clearance under K050805 and is classified as a Class II medical device with product code BRZ, regulated under 21 CFR 880.5440 for general hospital use.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 30 ML or 60 ML Pedi-Syringe Filter used for?

    This device is a pediatric syringe filter designed to filter blood or blood components during transfusion procedures, ensuring particulate removal before administration to pediatric patients.

  • How is the Pedi-Syringe Filter supplied and is it reusable?

    The device is supplied sterile and intended for single-use only; it must not be reprocessed or reused due to risks of contamination, degradation, or compromised filtration integrity after initial use.

  • What sizes or models are available for this syringe filter?

    The Pedi-Syringe Filter is available in two volume capacities: 30 mL and 60 mL, allowing clinicians to select the appropriate size based on the required transfusion volume for pediatric patients.

  • What regulatory clearance does this device have?

    The device has received FDA 510(k) clearance under submission number K050805, confirming its substantial equivalence to a legally marketed predicate device for general hospital use in blood transfusion.