# K190795: Tetragraph Neuromuscular Transmission Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Senzime AB
- Decided: Oct 18, 2019 after 204 days
- Product code: KOI (Stimulator, Nerve, Peripheral, Electric)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955026 (1997). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051635: Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and Accessories, GE Healthcare (2005) Summary page 5.

## Most influential descendants
- K201949: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (2021), 3 descendants of its own
- K220530: Tetragraph Neuromuscular Transmission Monitor (2022), 1 descendant of its own
- K213316: Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM (2021), 1 descendant of its own
- K261098: TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (2026), 0 descendants of its own
- K220976: Life Scope PT BSM-1700 Series Bedside Monitor (2022), 0 descendants of its own

## Indications for use
The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.

Source page: https://510kreport.com/device/K190795
Methodology: https://510kreport.com/methodology