# K050805: 30 ML or 60 ML Pedi-Syringe Filter

- Pathway: 510(k) (Traditional)
- Applicant: Blood Products Specialties, LLC
- Decided: Jun 20, 2005 after 82 days
- Product code: BRZ (Set, Blood Transfusion)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000685 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000685: Charter Medical Neonatal Syringe Set, Charter Medical, Ltd. (2000) Summary page 1.

## Recalls of this device
- Jul 17, 2014 · Class II · Z-2669-2014: Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
- Jul 17, 2014 · Class II · Z-2667-2014: Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
- Jul 17, 2014 · Class II · Z-2668-2014: Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

## Indications for use
Blood Product Specialties Pedi-Syringe Filter is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion.

Source page: https://510kreport.com/device/K050805
Methodology: https://510kreport.com/methodology