# K220530: Tetragraph Neuromuscular Transmission Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Senzime AB
- Decided: Aug 17, 2022 after 174 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: 38 generations back to K941811 (1994). 268 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 270 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190795: Tetragraph Neuromuscular Transmission Monitor, Senzime AB (2019) Summary page 4.
- K172690: ToFscan, Idmed (2018) Summary page 6.
- K210906: IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4, Philips Medizin Systeme Boeblingen GmbH (2021) Summary page 6.

## Most influential descendants
- 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

## 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/K220530
Methodology: https://510kreport.com/methodology