Clinic software
Nihon Kohden added alarm-silence after clearance, with no new 510(k)
FDA told Nihon Kohden Digital Health Solutions that a hospital monitoring program, Next Generation NetKonnect, was changed after clearance — a silent-alarms switch, and a claim that it would take inputs from other manufacturers’ devices — without a new 510(k).
The inspection of the Irvine, California firm ran February 23–24, 2026. The software is a class II arrhythmia detector and alarm under 21 CFR 870.1025, last cleared as K220989 on July 29, 2022. On October 22, 2022, the firm added a Silence Alarms function and filed it as a letter-to-file. At the “control mechanism” question on its own form, it checked no. FDA disagrees: silencing alarms changes how the user controls the device and “may result in missed alarms for life-threatening conditions.” That, the letter says, needs a new 510(k).
The labeling also claims “device-agnostic compatibility.” Management told investigators that meant any off-the-shelf computer and inputs from non-Nihon Kohden devices. The 2022 clearance, FDA writes, covered inputs from Nihon Kohden devices only. Unvalidated interoperability, the letter says, can produce wrong vital signs or a loss of monitoring.
This is a software-change letter, not a billing case. The product lives in the clinic: a monitor with an alarm the user can now turn off, talking to machines it was not cleared to hear.
Sources
Every statement above is taken from these public records.
These notes paraphrase and quote one public FDA warning letter. They are not legal advice. Redaction marks such as (b)(4) are FDA’s.