510(k) Report

510(k) · Cleared

Cleared

Charter Medical Neonatal Syringe Set

K000685510(k) TraditionalCleared Aug 15, 2000168-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

Charter Medical, Ltd. · BRZ Set, Blood Transfusion

Cleared on Aug 15, 2000 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 15, 2000
Review
168 days
Class
Class II
Product code
BRZ
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK000685 Charter Medical Neonatal Syringe SetCharter Medical, Ltd. · 2000
  2. Descendant · cites it directly · 0 of its ownK132905 200 Micron Blood Component Filter and Syringe AdapterArteriocyte Medical Systems, Inc. · 2013
  3. Descendant · cites it directly · 0 of its ownK050805 30 ML or 60 ML Pedi-Syringe FilterBlood Products Specialties, LLC · 2005 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K132905200 Micron Blood Component Filter and Syringe AdapterArteriocyte Medical Systems, Inc. · 2013 · cites it directly0descendants
  • K05080530 ML or 60 ML Pedi-Syringe FilterBlood Products Specialties, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000685Charter Medical Neonatal Syringe SetCharter Medical, Ltd.2000—
+1K132905200 Micron Blood Component Filter and Syringe AdapterArteriocyte Medical Systems, Inc.2013—
+1K05080530 ML or 60 ML Pedi-Syringe FilterBlood Products Specialties, LLC20053

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201310
FIG. 1 — Lineage of K000685, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132905200 Micron Blood Component Filter and Syringe AdapterArteriocyte Medical Systems, Inc.20130
K05080530 ML or 60 ML Pedi-Syringe FilterBlood Products Specialties, LLC20050

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?

  • Of its descendants, K132905 (Arteriocyte Medical Systems, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BRZ devices

BRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Charter Medical, Ltd.

2 FDA decisions under this applicant name. See the company

  • K990310Charter Medical, LTD MP 450 (40 Micron Filter)Charter Medical, Ltd. · 1999

Recent decisions in BRZ

The BRZ category page

  • K220558Blood Administration SetsBaxter Healthcare Corporation · 2022
  • K210335Blood Administration SetBaxter Healthcare Corporation · 2021
  • K132905200 Micron Blood Component Filter and Syringe AdapterArteriocyte Medical Systems, Inc. · 2013
  • 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

https://510kreport.com/device/K000685 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000685: Charter Medical Neonatal Syringe Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000685

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026