510(k) Report

FDA applicant

Kawasumi Laboratories Co., Ltd.

Tokyo, JP29 decisions1987–20191 recall

FDA records 29 decisions for Kawasumi Laboratories Co., Ltd. (Tokyo, JP) from 1987 to 2019: 29 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 15 predicates, 8 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Kawasumi Laboratories, Inc.”.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Kawasumi Laboratories Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2008: 12010: 22013: 12018: 12019: 2
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kawasumi Laboratories Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kawasumi Laboratories Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FPASet, Administration, Intravascular10decisions
  • FMINeedle, Hypodermic, Single Lumen5decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular4decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • FJIDialyzer, Capillary, Hollow Fiber1decision

Also: KZD (1), KSB (1), FKQ (1), FJK (1), KPE (1), LHI (1).

Whose devices does it build on?

Its devices cite 15 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 20082cite it
  • K060580K-Shield Port Access Infusion SetKawasumi Laboratories, Inc. · 20062cite it
  • K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc. · 20191cites it
  • K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 20101cites it
  • K023917Winged Needle Sets with an Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 20031cites it
  • K123344K-Shield Advantage Port Access Infusion Set (Pais)Kawasumi Laboratories, Inc. · 20131cites it

What has FDA decided for it lately?

  • 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
  • K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018
  • 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
  • K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2008
  • K061197Kawasumi Laboratories Empty Solution ContainerKawasumi Laboratories, Inc. · 2006

All 18 as Kawasumi Laboratories Co., Ltd. →All 11 as Kawasumi Laboratories, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K100720Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F…Nov 25, 2013Class II

Other applicant names beginning “Kawasumi”

FDA records each applicant name separately; these may or may not be the same firm.

Kawasumi Laboratories America, Inc. 6