510(k) · Cleared
ClearedEZ Stim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life-Tech Intl., Inc. · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on Dec 10, 1996 after a 439-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Dec 10, 1996
- Review
- 439 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK954505 EZ StimLife-Tech Intl., Inc. · 1996
- 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 · 3 generations on · 1 of its ownK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK260992 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe…Neuralytix · 2026
- Descendant · 2 generations on · 0 of its ownK213049 STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K102084Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010 · cites it directly6descendants
- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · 2 generations on2descendants
- K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025 · 3 generations on1descendant
- K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix · 2026 · 4 generations on0descendants
- K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954505 | EZ Stim | Life-Tech Intl., Inc. | 1996 | — |
| +1 | K102084 | Stimpod NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2010 | — |
| +2 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +3 | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | — |
| +4 | K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006)… | Neuralytix | 2026 | — |
| +2 | K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K102084 (Xavant Technology (Pty), Ltd., 2010) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K954505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954505: EZ Stim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954505
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026