510(k) · Cleared
ClearedNim-PRS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · IKN Electromyograph, Diagnostic
Cleared on Jan 6, 2003 as substantially equivalent to K982595 (Xomed, Inc., 1998) after an 11-day review. Its family tree reaches back 2 generations to 1994. 1 of the 34 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it.
- Decided
- Jan 6, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934426 (1994). 31 later devices descend from it, 1 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK934426 Nerve Integrity Monitor-2 (Nim-2 XL)Xomed-Treace, Inc. · 1994
- 1 generation backK982595 NIM4Xomed, Inc. · 1998
- This deviceK024316 Nim-PRSMedtronic Xomed, Inc. · 2003
- Descendant · cites it directly · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 2 generations on · 7 of its ownK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitor2 generations on · 2020
Most influential descendants
Showing 5 of 31 · See all- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · cites it directly30descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 2 generations on9descendants
- K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017 · 2 generations on7descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 2 generations on7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934426 | Nerve Integrity Monitor-2 (Nim-2 XL) | Xomed-Treace, Inc. | 1994 | — |
| −1 | K982595 | NIM4 | Xomed, Inc. | 1998 | — |
| 0 (this device) | K024316 | Nim-PRS | Medtronic Xomed, Inc. | 2003 | — |
| +1 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +2 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +2 | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +3 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 1 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K982595 | NIM4Summary page 2…ion, design, technology, system features, functions, and the principle of operation of the NIM-PRS are substantially equivalent to the Medtronic Xomed NIM-4 (K982 5 95). Characteristic NIM-4 (K982595) VIM-PRS… | 1998 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083124 | NIM 3.0 | 2009 | 30 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083124 (Medtronic Xomed, Inc., 2009) has gone furthest, with 30 descendants of its own.
- 1 other device also cites its predicate K982595.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKN
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · IKN
188in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKN
3in 2025
MAUDE reports naming product code IKN, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 3 | 188 | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024316 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024316: Nim-PRS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024316
Report an extraction error
Are you the manufacturer?
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