Nikkiso Medical America, Inc

Warning LetterClosed

Mr. Toshihiko Kai President & Chief Executive Officer Nikkiso Medical America, Inc 20-3, Ebisu 4-Chome, Shibuya-ku Tokyo , 150-6022 Japan T.Kai@nikkiso.co.jpIssued May 7, 2021Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateMay 7, 2021

Product TypeMedical Devices

StatusClosed

Closeout LetterJul 29, 2025

Letter Details

Firm: Nikkiso Medical America, Inc
Location: Mr. Toshihiko Kai President & Chief Executive Officer Nikkiso Medical America, Inc 20-3, Ebisu 4-Chome, Shibuya-ku Tokyo , 150-6022 Japan T.Kai@nikkiso.co.jp
FEI Number: N/A
Country: Japan
Issue Date: May 07, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: July 29, 2025

Summary

Nikkiso Medical America, Inc. was cited for marketing the DBB-06 dialysis device in the United States without required FDA premarket approval (PMA) or investigational device exemption (IDE), and for failing to submit a 510(k) premarket notification when introducing a physiological closed loop controller (PCLC) system—a significant modification that could affect device safety and effectiveness. The company's marketing materials demonstrated intent to commercialize the device with this new PCLC functionality, rendering the device both adulterated and misbranded under federal law.

Nikkiso Medical America, Inc FDA Warning Letter, May 7, 2021