510(k) · Cleared
ClearedNeuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii Nerve Mapping Probe, Neuro-Trace Iii Nerve BG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdc Corp. · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on Mar 2, 2004 as substantially equivalent to K883868 (Fisher & Paykel Electronics, Ltd., 1988) and 3 other predicates after a 512-day review. Its family tree reaches back 1 generation to 1988. 14 later devices descend from it.
- Decided
- Mar 2, 2004
- Review
- 512 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K882438 (1988). 4 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK882438 Constant Current Peripheral Nerve Stim. #NS252Fisher & Paykel Healthcare, Ltd. · 1988
- This deviceK023342 Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable…Hdc Corp. · 2004
- Descendant · cites it directly · 12 of its ownK072092 Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007
- Descendant · cites it directly · 10 of its ownK093591 Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009
- Descendant · cites it directly · 6 of its ownK102084 Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010
- Descendant · 2 generations on · 2 of its ownK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- Descendant · 2 generations on · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K072092Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007 · cites it directly12descendants
- K093591Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009 · cites it directly10descendants
- K102084Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010 · cites it directly6descendants
- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · 2 generations on2descendants
- K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882438 | Constant Current Peripheral Nerve Stim. #NS252 | Fisher & Paykel Healthcare, Ltd. | 1988 | — |
| 0 (this device) | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii… | Hdc Corp. | 2004 | — |
| +1 | K072092 | Xpod/Xmap Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2007 | — |
| +1 | K093591 | Stimpod Model NMS-400 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2009 | — |
| +1 | K102084 | Stimpod NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2010 | — |
| +2 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +2 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K883868 | Model NS242 Constant Current Peripheral Nerve StimSummary page 1…(202) 637-5794 - Telephone (202) 637-5910 - Facsimile Predicate Devices: Fisher & Paykel Innervator 242 - K883868 Fisher & Paykel Innervator 252 - K882438 Organon Teknika TOF Watch S - K992596 Life-Tech MaxiStim - K955031 Intended Use/Indicat… | 1988 |
| * | K882438 | Constant Current Peripheral Nerve Stim. #NS252Summary page 1…94 - Telephone (202) 637-5910 - Facsimile Predicate Devices: Fisher & Paykel Innervator 242 - K883868 Fisher & Paykel Innervator 252 - K882438 Organon Teknika TOF Watch S - K992596 Life-Tech MaxiStim - K955031 Intended Use/Indications: The NeuroTrace III ca… | 1988 |
| * | K992596 | Tof-Watch SSummary page 1…(202) 637-5910 - Facsimile Predicate Devices: Fisher & Paykel Innervator 242 - K883868 Fisher & Paykel Innervator 252 - K882438 Organon Teknika TOF Watch S - K992596 Life-Tech MaxiStim - K955031 Intended Use/Indications: The NeuroTrace III can be used as an objective monitor usin… | 1999 |
| * | K955031 | MaxistimSummary page 1…csimile Predicate Devices: Fisher & Paykel Innervator 242 - K883868 Fisher & Paykel Innervator 252 - K882438 Organon Teknika TOF Watch S - K992596 Life-Tech MaxiStim - K955031 Intended Use/Indications: The NeuroTrace III can be used as an objective monitor using accelerometry for measuring… | 1996 |
What descends from it? (14)
See all 144 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K072092 (Xavant Technology (Pty), Ltd., 2007) has gone furthest, with 12 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.
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 NeuroTrace III can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the respective motor neuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and for locating specific nerves. It is particularly useful in nerve block procedures to obtain effective regional anesthesia blocks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023342: Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii Nerve Mapping Probe, Neuro-Trace Iii Nerve BG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023342
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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