510(k) · Cleared
ClearedToFscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Idmed · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on May 31, 2018 as substantially equivalent to K972698 (Organon Teknika Corp., 1997) after a 267-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- May 31, 2018
- Review
- 267 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972698 (1997). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK972698 Tof-WatchOrganon Teknika Corp. · 1997
- This deviceK172690 ToFscanIdmed · 2018
- Descendant · cites it directly · 1 of its ownK220530 Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2022
- Descendant · 2 generations on · 0 of its ownK261098 TetraGraph Neuromuscular Transmission Monitor (SEN…Senzime AB · 2026
- Descendant · cites it directly · 0 of its ownK243339 WiTOFIdmed · 2025
- Descendant · cites it directly · 0 of its ownK242525 iTOF®Nerbio Medical Software Platforms, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB · 2022 · cites it directly1descendant
- K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB · 2026 · 2 generations on0descendants
- K243339WiTOFIdmed · 2025 · cites it directly0descendants
- K242525iTOF®Nerbio Medical Software Platforms, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972698 | Tof-Watch | Organon Teknika Corp. | 1997 | — |
| 0 (this device) | K172690 | ToFscan | Idmed | 2018 | — |
| +1 | K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022 | — |
| +2 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens… | Senzime AB | 2026 | — |
| +1 | K243339 | WiTOF | Idmed | 2025 | — |
| +1 | K242525 | iTOF® | Nerbio Medical Software Platforms, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K972698 | Tof-WatchSummary page 4…duct Code: KOI Regulatory Class: Class II 5.3. Predicate device Predicate Device: TOF-Watch, manufactured by Organon Teknika, K972698 510(k) – ToFscan CONFIDENTIAL 5-1… | 1997 |
What descends from it? (4)
3 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?
How does its category compare?
All KOI devicesKOI Stimulator, Nerve, Peripheral, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 TOFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
The effect of neuromuscular blocking agents (NMBAs) is monitored by measuring the acceleration of the muscle movement (acceleromyography) or by visually observing muscle contractions consequent to electrical stimulation. The TOFscan has a three-dimensional acceleration sensor (accelerometer) to detect and quantify a patient’s thumb movement (contracting adductor pollicis). The sensor is directly integrated into the finger’s splint, making it possible to obtain its optimal and reproducible positioning.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172690: ToFscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172690
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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