510(k) Report

510(k) · Cleared

Cleared

Kawasumi Laboratory Blood Drawing Kit

K001043510(k) TraditionalCleared May 19, 200049-day reviewClass II21 CFR 864.9875

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

Kawasumi Laboratories America, Inc. · KSB Set, Transfer (Blood/Plasma)

Cleared on May 19, 2000 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 19, 2000
Review
49 days
Class
Class II
Product code
KSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2018: 1 descendant cleared2010: 1 descendant cleared200020052010201520202025
  1. This deviceK001043 Kawasumi Laboratory Blood Drawing KitKawasumi Laboratories America, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK073257 Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2008
  3. Descendant · 2 generations on · 1 of its ownK102994 K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010
  4. Descendant · cites it directly · 0 of its ownK172957 Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2008 · cites it directly2descendants
  • K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010 · 2 generations on1descendant
  • K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001043Kawasumi Laboratory Blood Drawing KitKawasumi Laboratories America, Inc.2000—
+1K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc.2008—
+2K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc.2010—
+1K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201810
FIG. 1 — Lineage of K001043, 2000–2018Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc.20082
K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.20180

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, K073257 (Kawasumi Laboratories, Inc., 2008) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KSB devices

KSB Set, Transfer (Blood/Plasma): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KSB

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KSB

Too few KSB 510(k)s in any year since 2007 to give a median.

Recalls per year · KSB

No recall names KSB since 2007.

Adverse event reports per year · KSB

11in 2019

2009: 12011: 12015: 12016: 12017: 262018: 92019: 11
2007high 26 (2017) · low 0 (2007)2025

MAUDE reports naming product code KSB, 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—00
20080—00
20090—01
20100—00
20110—01
20120—00
20130—00
20140—00
20150—01
20160—01
20170—026
20181—09
20190—011
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Kawasumi Laboratories America, Inc.

6 FDA decisions under this applicant name. See the company

  • K102890K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and Multisample Luer…Kawasumi Laboratories America, Inc. · 2010
  • K030385IV Add-on Filter Administration Set with and Without Y Connect or Needleless Access ConnectorKawasumi Laboratories America, Inc. · 2003
  • K001426Kawasumi Laboratories IV Administration Set with FilterKawasumi Laboratories America, Inc. · 2000
  • K001423Kawasumi Laboratories IV Administration Set, PrimaryKawasumi Laboratories America, Inc. · 2000
  • K001424Kawasumi Laboratories IV Administration Set, StandardKawasumi Laboratories America, Inc. · 2000

Recent decisions in KSB

The KSB category page

  • K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018
  • K820447Alpha Plasma Transfer SetAlpha Therapeutic Corp. · 1982
  • K802940Super-Spike Transfer SetGeneva Laboratories, Inc. · 1981
  • K791131Flu Ven TR-1Venospital, Inc. · 1979
  • K791130Flu-Ven TK-2Venospital, Inc. · 1979

https://510kreport.com/device/K001043 · printed Nov 3, 2026

Cite this page

510(k) Report. “K001043: Kawasumi Laboratory Blood Drawing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001043

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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