510(k) · Cleared
ClearedTetragraph Neuromuscular Transmission Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senzime AB · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on Oct 18, 2019 as substantially equivalent to K051635 (GE Healthcare, 2005) after a 204-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Oct 18, 2019
- Review
- 204 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955026 (1997). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955026 AS/3 NMT ModuleDatex Medical Instrumentation, Inc. · 1997 · Recalled
- 1 generation backK051635 Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and…GE Healthcare · 2005 · Recalled
- This deviceK190795 Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2019
- Descendant · cites it directly · 3 of its ownK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
- Descendant · cites it directly · 1 of its ownK220530 Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2022
- Descendant · 2 generations on · 1 of its ownK213316 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit…Nihon Kohden Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK261098 TetraGraph Neuromuscular Transmission Monitor (SEN…Senzime AB · 2026
- Descendant · 3 generations on · 0 of its ownK220976 Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation · 2021 · cites it directly3descendants
- K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2022 · cites it directly1descendant
- K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…Nihon Kohden Corporation · 2021 · 2 generations on1descendant
- K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB · 2026 · 2 generations on0descendants
- K220976Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955026 | AS/3 NMT Module | Datex Medical Instrumentation, Inc. | 1997 | 1 |
| −1 | K051635 | Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and Accessories | GE Healthcare | 2005 | 1 |
| 0 (this device) | K190795 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2019 | — |
| +1 | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life… | Nihon Kohden Corporation | 2021 | — |
| +1 | K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022 | — |
| +2 | K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE… | Nihon Kohden Corporation | 2021 | — |
| +2 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens… | Senzime AB | 2026 | — |
| +3 | K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2026 | 1 | 0 |
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 K261098 TetraGraph Neuromuscular Transmission Monitor…score 21.1 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051635 | Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and AccessoriesSummary page 5…Page 2 of 7 Senzime AB Traditional 510(k) Premarket Submission TetraGraph 5. Legally Marketed Predicate and Reference Devices Predicate Device- K051635, Datex Ohmeda S/5 NeuroMuscular Transmission Module, E- NMT (from GE Healthcare) Reference Device - K992598, TOF-Watch SX… | 2005 |
| † | K992598 | Tof-Watch SX | 1999 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K201949 (Nihon Kohden Corporation, 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KOI devicesKOI Stimulator, Nerve, Peripheral, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KOI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOI
174in 2022
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
MAUDE reports naming product code KOI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 3 | 174 | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190795 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190795: Tetragraph Neuromuscular Transmission Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190795
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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