# K261098: TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)

- Pathway: 510(k) (Special)
- Applicant: Senzime AB
- Decided: May 22, 2026 after 50 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: 39 generations back to K941811 (1994). 269 ancestors in all.
No later device cites it as a predicate yet.
1 of 270 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220530: Tetragraph Neuromuscular Transmission Monitor, Senzime AB (2022) Summary page 5.

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

Source page: https://510kreport.com/device/K261098
Methodology: https://510kreport.com/methodology