510(k) Report

510(k) · Cleared

Cleared

Kawasumi Laboratories Blood Drawing Kit (BDK) System

K172957510(k) TraditionalCleared Sep 28, 2018367-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, Inc. · KSB Set, Transfer (Blood/Plasma)

Cleared on Sep 28, 2018 as substantially equivalent to K001043 (Kawasumi Laboratories America, Inc., 2000) and 2 other predicates after a 367-day review. Its family tree reaches back 3 generations to 1997.

Decided
Sep 28, 2018
Review
367 days
Class
Class II
Product code
KSB
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K970259 (1997). 8 ancestors in all, the oldest K873421 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2000: 2 other ancestors1994: 1 other ancestor1987: 1 other ancestorK970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 1997K980414 · Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · recalledK102994 · K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector · Kawasumi Laboratories, Inc. · 201019851990199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors K102994 · K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector · Kawasumi Laboratories, Inc. · 2010K980414 · Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · recalledK970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 19970
  1. Root · 3 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
  2. 2 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
  3. 1 generation backK102994 K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010
  4. This deviceK172957 Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970259E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc.1997—
−2K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer…Bd Becton Dickinson Vacutainer Systems Preanalytic19981
−1K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc.2010—
0 (this device)K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
200020
200810
FIG. 1 — Lineage of K172957, 1997–2018Source: 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), 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 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? (3)

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
*K001043Kawasumi Laboratory Blood Drawing Kit
Summary page 4
…t to Kawasumi Laboratories’ own predicate device(s) including the following Primary Predicate Device: • Kawasumi Laboratories Blood Drawing Kit - cleared under (K001043) IV. DEVICE DESCRIPTION The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access…
Kawasumi Laboratories America, Inc.2000—
*K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector
Summary page 6
…to a blood bag reservoir. The Stick Protector same for Use withdrawal. Use of the Needleless Access collected blood is properly discarded and not as K073257 and Connector allows the clinician needle-free intended for transfusion. K102994…
Kawasumi Laboratories, Inc.2008—
*K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector
Summary page 6
…blood is properly discarded and not as K073257 and Connector allows the clinician needle-free intended for transfusion. K102994 blood withdrawal when blood sampling is required. The Antineedle Stick Protector is This 51…
Kawasumi Laboratories, Inc.2010—

Also cleared against K001043: 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?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 1 other device also cites its predicate K001043.

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. 2018, this device’s year, is highlighted.

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—

What is it indicated for?

The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.

Indications for use as stated in the FDA summary.

Also cleared against K001043

1 other device cites the same predicate.

  • K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2008

More from Kawasumi Laboratories, Inc.

11 FDA decisions under this applicant name. See the company

  • K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc. · 2019
  • K190233K-Shield Advantage Port Access Infusion Set (PAIS)Kawasumi Laboratories, Inc. · 2019
  • K123344K-Shield Advantage Port Access Infusion Set (Pais)Kawasumi Laboratories, Inc. · 2013
  • K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc. · 20101 recall
  • K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010

Recent decisions in KSB

The KSB category page

  • K001043Kawasumi Laboratory Blood Drawing KitKawasumi Laboratories America, Inc. · 2000
  • 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/K172957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172957: Kawasumi Laboratories Blood Drawing Kit (BDK) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172957

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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