510(k) · Cleared
ClearedConstant Current Peripheral Nerve Stimulator NS272 (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on May 23, 1996 as substantially equivalent to K924234 (Fisher & Paykel Electronics, Ltd., 1993) after a 359-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- May 23, 1996
- Review
- 359 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924234 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK924234 Cons. Current Periph. Nerve Loc. NS232,NS262,NS272Fisher & Paykel Electronics, Ltd. · 1993
- This deviceK953205 Constant Current Peripheral Nerve Stimulator NS272 (Modification)Fisher & Paykel Healthcare, Ltd. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924234 | Cons. Current Periph. Nerve Loc. NS232,NS262,NS272 | Fisher & Paykel Electronics, Ltd. | 1993 | — |
| 0 (this device) | K953205 | Constant Current Peripheral Nerve Stimulator NS272 (Modification) | Fisher & Paykel Healthcare, Ltd. | 1996 | — |
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 |
|---|---|---|---|
| * | K924234 | Cons. Current Periph. Nerve Loc. NS232,NS262,NS272Summary page 1…on Name: Stimulator, Nerve, Peripheral, Electric - 73 KOI Anesthesiology Devices, 21 CFR §868.2775 Predicate Device: Fisher & Paykel, NS272 Nerve Stimulator / Locator, K924234 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 intended use of the NS272 is for the application of an electrical current to a patient in External (nerve stimulation) and Internal (nerve location) modes of operation. In External mode this is to test the level of pharmacological effect of anesthetic drugs and gases for neuromuscular blaockade monitoring. In Internal mode this is for the location of nerves for the administering of anesthetic drugs to accurately achieve neuromuscular blockage.
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/K953205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953205: Constant Current Peripheral Nerve Stimulator NS272 (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953205
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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