510(k) · Cleared
ClearedCons. Current Periph. Nerve Loc. NS232,NS262,NS272
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Electronics, Ltd. · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on May 27, 1993 after a 276-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.
- Decided
- May 27, 1993
- Review
- 276 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK924234 Cons. Current Periph. Nerve Loc. NS232,NS262,NS272Fisher & Paykel Electronics, Ltd. · 1993
- Descendant · cites it directly · 0 of its ownK953205 Constant Current Peripheral Nerve Stimulator NS272 (Modification)Fisher & Paykel Healthcare, Ltd. · 1996
Most influential descendants
Showing 1 of 1 · See all- K953205Constant Current Peripheral Nerve Stimulator NS272 (Modification)Fisher & Paykel Healthcare, Ltd. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924234 | Cons. Current Periph. Nerve Loc. NS232,NS262,NS272 | Fisher & Paykel Electronics, Ltd. | 1993 | — |
| +1 | K953205 | Constant Current Peripheral Nerve Stimulator NS272 (Modification) | Fisher & Paykel Healthcare, Ltd. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K953205 | Constant Current Peripheral Nerve Stimulator NS272 (Modification) | 1996 | 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?
- Of its descendants, K953205 (Fisher & Paykel Healthcare, Ltd., 1996) has gone furthest, with 0 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/K924234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924234: Cons. Current Periph. Nerve Loc. NS232,NS262,NS272.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924234
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026