510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

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

K051635510(k) SpecialCleared Jul 15, 200525-day reviewClass II21 CFR 868.2775Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Healthcare · KOI Stimulator, Nerve, Peripheral, Electric

Cleared on Jul 15, 2005 as substantially equivalent to K955026 (Datex Medical Instrumentation, Inc., 1997) after a 25-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it. It has been recalled once.

Decided
Jul 15, 2005
Review
25 days
Class
Class II
Product code
KOI
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K955026 (1997). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2022: 2 descendants cleared2021: 3 descendants cleared2026: 1 descendant clearedK955026 · AS/3 NMT Module · Datex Medical Instrumentation, Inc. · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K955026 · AS/3 NMT Module · Datex Medical Instrumentation, Inc. · 1997 · recalled0
  1. Root · 1 generation backK955026 AS/3 NMT ModuleDatex Medical Instrumentation, Inc. · 1997 · Recalled
  2. This deviceK051635 Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and…GE Healthcare · 2005
  3. Descendant · cites it directly · 6 of its ownK190795 Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2019
  4. Descendant · 2 generations on · 3 of its ownK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
  5. Descendant · 2 generations on · 1 of its ownK220530 Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2022
  6. Descendant · 3 generations on · 1 of its ownK213316 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit…Nihon Kohden Corporation · 2021
  7. Descendant · 3 generations on · 0 of its ownK261098 TetraGraph Neuromuscular Transmission Monitor (SEN…Senzime AB · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2019: 12021: 32022: 22026: 1
2019high 3 (2021) · low 0 (2020)2026

Most influential descendants

Showing 5 of 7 · See all
  • K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2019 · cites it directly6descendants
  • K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation · 2021 · 2 generations on3descendants
  • K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2022 · 2 generations on1descendant
  • K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…Nihon Kohden Corporation · 2021 · 3 generations on1descendant
  • K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K955026AS/3 NMT ModuleDatex Medical Instrumentation, Inc.19971
0 (this device)K051635Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and AccessoriesGE Healthcare2005—
+1K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB2019—
+2K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life…Nihon Kohden Corporation2021—
+2K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB2022—
+3K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE…Nihon Kohden Corporation2021—
+3K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens…Senzime AB2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202130
202220
202610
FIG. 1 — Lineage of K051635, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KOI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KOI device

  1. #1 K261098 TetraGraph Neuromuscular Transmission Monitor…score 21.1 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K955026AS/3 NMT Module
Summary page 1
…uscular Transmission Module, E-NMT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NMT Module (K955026). Page 2 of 4 DE…
Datex Medical Instrumentation, Inc.19971

Also cleared against K955026: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB20196

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 9, 2014Class IIZ-1640-2014Software designWhen 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 relaxation. In the clinical situation…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K190795 (Senzime AB, 2019) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K955026.

How does its category compare?

All KOI devices

KOI Stimulator, Nerve, Peripheral, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOI

2in 2025

2016: 12018: 22019: 12020: 12021: 22022: 32024: 12025: 22026 (partial year): 1
2007high 3 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KOI

174in 2022

2022: 174 days median
2007high 174 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KOI

No recall names KOI since 2007.

Adverse event reports per year · KOI

5in 2025

2011: 12012: 32013: 22014: 92015: 12018: 12019: 42020: 42021: 32022: 42023: 12024: 22025: 5
2007high 9 (2014) · low 0 (2007)2025

MAUDE reports naming product code KOI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—03
20130—02
20140—09
20150—01
20161—00
20170—00
20182—01
20191—04
20201—04
20212—03
2022317404
20230—01
20241—02
20252—05
20261—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K955026

1 other device cites the same predicate.

  • K061113OrthomonAxon Systems, Inc. · 2006

More from GE Healthcare

223 FDA decisions under this applicant name. See the company

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Recent decisions in KOI

The KOI category page

  • K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric…Senzime AB · 2026
  • K250887Neuromuscular Transmission Monitor TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbH · 2025
  • K243339WiTOFIdmed · 2025
  • K242525iTOF®Nerbio Medical Software Platforms, Inc. · 2024
  • K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2022

https://510kreport.com/device/K051635 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051635: Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051635

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026