510(k) · Cleared
ClearedTwitchView System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blink Device Corporation · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on Mar 29, 2018 as substantially equivalent to K972698 (Organon Teknika Corp., 1997) after a 191-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Mar 29, 2018
- Review
- 191 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972698 (1997). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K181894TOF-Cuff monitorRgb Medical Devices SA · 2019 · 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) | K172843 | TwitchView System | Blink Device Corporation | 2018 | — |
| +1 | K181894 | TOF-Cuff monitor | Rgb Medical Devices SA | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 5…bulated below. Predicate/Reference Device 510(k) TOF Watch (Predicate Device) K972698 GE CARESCAPE B450 (Reference Device) K132533 Xavant Stimpod (Reference Device… | 1997 |
| † | K132533 | Carescape Monitor B450 | 2013 |
| † | K102084 | Stimpod NMS450 Nerve Stimulator | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181894 | TOF-Cuff monitor | 2019 | 0 |
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 TwitchView System is used for the quantitative monitoring of neuromuscular transmission by means of electromyography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172843: TwitchView System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172843
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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