Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1055927

FEI Number

1000113359

Entity Name

KAWASUMI LABORATORIES AMERICA, INC.

City/State/Country

Tampa, FL, US

Establishment Address

10002 PRINCESS PALM AVENUE, SUITE 324, Tampa, FL 33619, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

SB-KAWASUMI LABORATORIES, INC. (Owner Number: 8031539)

Owner / Operator Contact Address

3-25-4 Tonomachi, Kawasaki-ku, Kawasaki-shi, JP-14 210-8602, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001424

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-07-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-03-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-04-20
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2026-04-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-03-03

Official Correspondent

Kenichi Inamura

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SB-KAWASUMI LABORATORIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010141954	Sumitomo Bakelite (Dongguan) Co., Ltd.	Dongguan Guangdong, CN
3002806337	Akita Sumitomo Bakelite Co., Ltd.	Akita, JP
9615908	KAWASUMI LABORATORIES (THAILAND) CO., LTD.	CHOK CHAI Nakhon Ratchasima, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055927. Last updated year: 2026. Please use registration number 1055927 when referencing this establishment in official correspondence.