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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Nikkiso Medical America, Inc

Issued · Posted by FDA

FDA published a close-out letter on Jul 29, 2025. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The DBB-06 is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with a significant change or modification, specifically the introduction of a physiological closed loop controller (PCLC) system (also referred to as PCLC function or functionality in this letter) which is a change or modification in the device that could significantly affect the safety or effectiveness of the device, without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 807.81(a)(3)
  • 21 CFR 807.81(b)