# K181894: TOF-Cuff monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Rgb Medical Devices SA
- Decided: May 9, 2019 after 297 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K903134 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181104: Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style, Shenzhen Combei Technology Co., Ltd. (2018). Cleared while this submission was under review Summary page 6.
- K172843: TwitchView System, Blink Device Corporation (2018) Summary page 6.

## Indications for use
TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and non-invasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device. The monitor should be used exclusively in health institutions by trained medical professionals. The monitor is suitable for use in the presence of electrosurgery. Monitor is not intended to be used in the home environment. The monitor should be used only with a single patient.

Source page: https://510kreport.com/device/K181894
Methodology: https://510kreport.com/methodology