510(k) · Cleared
ClearedNicolet Viking II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Instrument Corp. · IKN Electromyograph, Diagnostic
Cleared on Mar 16, 1989 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 70 devices in its family, counting itself, has a Class I recall. 69 later devices descend from it.
- Decided
- Mar 16, 1989
- Review
- 43 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 5 citing it directly. 1 of the 70 devices in this family, counting this one, has a Class I recall.
- This deviceK890495 Nicolet Viking II SystemNicolet Instrument Corp. · 1989
- Descendant · cites it directly · 40 of its ownK031510 Nim-SpineMedtronic Xomed · 2003
- Descendant · cites it directly · 30 of its ownK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 2 generations on · 30 of its ownK083124 NIM 3.0Medtronic Xomed, Inc. · 2009 · Recalled
- Descendant · cites it directly · 16 of its ownK070608 Smartep, Model M010000Intelligent Hearing Systems · 2007
- Descendant · 2 generations on · 12 of its ownK162383 Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200759 NIM Vital, Nerve Integrity Monitor3 generations on · 2020
Most influential descendants
Showing 5 of 69 · See all- K031510Nim-SpineMedtronic Xomed · 2003 · cites it directly40descendants
- K112052Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · cites it directly30descendants
- K083124NIM 3.0Medtronic Xomed, Inc. · 2009 · 2 generations on30descendants
- K070608Smartep, Model M010000Intelligent Hearing Systems · 2007 · cites it directly16descendants
- K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890495 | Nicolet Viking II System | Nicolet Instrument Corp. | 1989 | — |
| +1 | K031510 | Nim-Spine | Medtronic Xomed | 2003 | — |
| +1 | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +2 | K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009 | 3 |
| +1 | K070608 | Smartep, Model M010000 | Intelligent Hearing Systems | 2007 | — |
| +2 | K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 1 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (69)
See all 695 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K031510 (Medtronic Xomed, 2003) has gone furthest, with 40 descendants of its own.
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 | — |
https://510kreport.com/device/K890495 · printed Nov 5, 2026
Cite this page
510(k) Report. “K890495: Nicolet Viking II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890495
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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