510(k) · Cleared
Recalled · Class II · 201430 ML or 60 ML Pedi-Syringe Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blood Products Specialties, LLC · BRZ Set, Blood Transfusion
Cleared on Jun 20, 2005 as substantially equivalent to K000685 (Charter Medical, Ltd., 2000) after an 82-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 3 times.
- Decided
- Jun 20, 2005
- Review
- 82 days
- Class
- Class II
- Product code
- BRZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000685 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000685 Charter Medical Neonatal Syringe SetCharter Medical, Ltd. · 2000
- This deviceK050805 30 ML or 60 ML Pedi-Syringe FilterBlood Products Specialties, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000685 | Charter Medical Neonatal Syringe Set | Charter Medical, Ltd. | 2000 | — |
| 0 (this device) | K050805 | 30 ML or 60 ML Pedi-Syringe Filter | Blood Products Specialties, LLC | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BRZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BRZ device
- #1 K220558 Blood Administration Setsscore 4.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000685 | Charter Medical Neonatal Syringe SetSummary page 1…88 Class: II Panel: 80 Product code: 3IL , Predicate Device: Charter Medical Neonatal Syringe Set (K000685) Device Description: IFubinsŽ assembly with a 150 micron filter connected by tubing to a sp… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2014 | Class II | Z-2669-2014 | No Marketing Application | 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 | No Marketing Application | 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 | No Marketing Application | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K000685.
How does its category compare?
All BRZ devicesBRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BRZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · BRZ
Too few BRZ 510(k)s in any year since 2007 to give a median.
Recalls per year · BRZ
No recall names BRZ since 2007.
Adverse event reports per year · BRZ
70in 2025
MAUDE reports naming product code BRZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 12 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 71 |
| 2011 | 0 | — | 0 | 123 |
| 2012 | 0 | — | 0 | 141 |
| 2013 | 1 | — | 0 | 175 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 0 | — | 0 | 171 |
| 2016 | 0 | — | 0 | 78 |
| 2017 | 0 | — | 0 | 82 |
| 2018 | 0 | — | 0 | 66 |
| 2019 | 0 | — | 0 | 85 |
| 2020 | 0 | — | 0 | 90 |
| 2021 | 1 | — | 0 | 60 |
| 2022 | 1 | — | 0 | 55 |
| 2023 | 0 | — | 0 | 67 |
| 2024 | 0 | — | 0 | 89 |
| 2025 | 0 | — | 0 | 70 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050805: 30 ML or 60 ML Pedi-Syringe Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050805
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026