510(k) Report

510(k) · Cleared

Cleared

200 Micron Blood Component Filter and Syringe Adapter

K132905510(k) TraditionalCleared Oct 4, 201318-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arteriocyte Medical Systems, Inc. · BRZ Set, Blood Transfusion

Cleared on Oct 4, 2013 as substantially equivalent to K000685 (Charter Medical, Ltd., 2000) after an 18-day review. Its family tree reaches back 1 generation to 2000.

Decided
Oct 4, 2013
Review
18 days
Class
Class II
Product code
BRZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000685 (2000). No later device cites it as a predicate yet.

K000685 · Charter Medical Neonatal Syringe Set · Charter Medical, Ltd. · 20002000200520102015
K000685 · Charter Medical Neonatal Syringe Set · Charter Medical, Ltd. · 20000
  1. Root · 1 generation backK000685 Charter Medical Neonatal Syringe SetCharter Medical, Ltd. · 2000
  2. This deviceK132905 200 Micron Blood Component Filter and Syringe AdapterArteriocyte Medical Systems, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000685Charter Medical Neonatal Syringe SetCharter Medical, Ltd.2000—
0 (this device)K132905200 Micron Blood Component Filter and Syringe AdapterArteriocyte Medical Systems, Inc.2013—
FIG. 1 — Lineage of K132905, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220558 Blood Administration Setsscore 4.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K000685Charter Medical Neonatal Syringe Set
Summary page 1
…ame: Fluid Reservoir and Delivery System Predicate Device: Charter Medical, Ltd: 150 Neonatal Syringe Set with 150 Micron Filter - K000685 Charter Medical, Ltd: Adult Blood Component Recipient Set with 150 Micron Filter -…
Charter Medical, Ltd.2000—
*—Adult Blood Component Recipient Set with 150 Micron Filter
Named without a submission number
—

Also cleared against K000685: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

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 devices

BRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · BRZ

1in 2022

2008: 12009: 12013: 12021: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

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

2007: 122008: 122009: 172010: 712011: 1232012: 1412013: 1752014: 1082015: 1712016: 782017: 822018: 662019: 852020: 902021: 602022: 552023: 672024: 892025: 70
2007high 175 (2013) · low 12 (2007)2025

MAUDE reports naming product code BRZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—012
20081—012
20091—017
20100—071
20110—0123
20120—0141
20131—0175
20140—0108
20150—0171
20160—078
20170—082
20180—066
20190—085
20200—090
20211—060
20221—055
20230—067
20240—089
20250—070
20260—0—

What is it indicated for?

The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.

Indications for use as stated in the FDA summary.

Also cleared against K000685

1 other device cites the same predicate.

  • K05080530 ML or 60 ML Pedi-Syringe FilterBlood Products Specialties, LLC · 20053 recalls

Recent decisions in BRZ

The BRZ category page

  • K220558Blood Administration SetsBaxter Healthcare Corporation · 2022
  • K210335Blood Administration SetBaxter Healthcare Corporation · 2021
  • K083349Blood Transfusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009
  • K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer ConnectorFenwal, Inc. · 2008
  • K041496Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 2005

https://510kreport.com/device/K132905 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132905: 200 Micron Blood Component Filter and Syringe Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132905

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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