# K051635: Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and Accessories

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jul 15, 2005 after 25 days
- Product code: KOI (Stimulator, Nerve, Peripheral, Electric)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955026 (1997). 1 ancestor in all.
7 later devices descend from it; 1 cites 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)
- K955026: AS/3 NMT Module, Datex Medical Instrumentation, Inc. (1997) Summary page 1.

## Most influential descendants
- K190795: Tetragraph Neuromuscular Transmission Monitor (2019), 6 descendants of its own
- 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

## Recalls of this device
- Apr 9, 2014 · Class II · Z-1640-2014: When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle rel

## Indications for use
The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K051635
Methodology: https://510kreport.com/methodology