# K955026: AS/3 NMT Module

- Pathway: 510(k) (Traditional)
- Applicant: Datex Medical Instrumentation, Inc.
- Decided: Apr 28, 1997 after 543 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
No predicates in its family tree.
459 later devices descend from it; 2 cite it directly.
1 of 460 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061113: Orthomon (2006), 450 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own
- K123270: Powerease System (2013), 398 descendants of its own
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), 396 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 product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

Source page: https://510kreport.com/device/K955026
Methodology: https://510kreport.com/methodology