510(k) · Cleared
ClearedNeuromuscular Transmission Monitor TOF3D (2510091)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MIPM Mammendorfer Institut für Physik und Medizin GmbH · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on Oct 21, 2025 as substantially equivalent to K212434 (MIPM Mammendorfer Institut für Physik und Medizin GmbH, 2022) after a 210-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Oct 21, 2025
- Review
- 210 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992598 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK992598 Tof-Watch SXOrganon Teknika Corp. · 1999
- 1 generation backK212434 Neuromuscular Transmission Monitor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbH · 2022
- This deviceK250887 Neuromuscular Transmission Monitor TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992598 | Tof-Watch SX | Organon Teknika Corp. | 1999 | — |
| −1 | K212434 | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2022 | — |
| 0 (this device) | K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2025 | — |
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 |
|---|---|---|---|
| * | K212434 | Neuromuscular Transmission Monitor TOF3DSummary page 5…lass II Product Code: KOI 1.4 Legally Marketed Predicate Devices Predicate 510(k) number: K212434 Predicate Trade Name: TOF3D Product Code: KOI M… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 2 companies; a new generation was cleared every 22.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All KOI devicesKOI Stimulator, Nerve, Peripheral, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The TOF3D is intended for use by specialists, anesthetists and nurses with specialization in anesthesia care. Patients: The device is intended for use for adolescents greater than 18 through…
Read the full statement (131 words)
The TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring.
The TOF3D is intended for use by specialists, anesthetists and nurses with specialization in anesthesia care.
Patients:
The device is intended for use for adolescents greater than 18 through 21 years of age, and adults.
Excluded operating environment:
The device is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, hyperbaric chambers, explosive, flammable and oxygen rich environment or environment with sources of intense electromagnetic disturbances. (e.g. Radio Frequency (RF) shielded room of magnetic resonance imaging equipment, electrophysiology laboratories or areas where short or micro wave therapy equipment is used)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250887: Neuromuscular Transmission Monitor TOF3D (2510091).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250887
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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