510(k) · Cleared
ClearedNatus VikingQuest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Neurology Incorporated · IKN Electromyograph, Diagnostic
Cleared on Dec 19, 2017 as substantially equivalent to K130346 (Natus Neurology Incorporated, 2013) and 1 other predicate after a 98-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- Dec 19, 2017
- Review
- 98 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K802637 (1980). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 7 generations backK982359 NC-StatNeurometrix, Inc. · 1998
- 6 generations backK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- 5 generations backK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- 4 generations backK060584 NC-StatNeurometrix, Inc. · 2006
- 3 generations backK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
- 2 generations backK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- 1 generation backK130346 Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated · 2013
- This deviceK172743 Natus VikingQuestNatus Neurology Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| −7 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| −6 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| −5 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| −4 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| −3 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
| −2 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| −1 | K130346 | Synergy Focus Desktop Version; Synergy Focus Laptop Version | Natus Neurology Incorporated | 2013 | — |
| 0 (this device) | K172743 | Natus VikingQuest | Natus Neurology Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 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.
Planning a device in IKN? 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? (2)
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 |
|---|---|---|---|
| * | K130346 | Synergy Focus Desktop Version; Synergy Focus Laptop VersionSummary page 4…Predicate 510(k) Predicate Equivalent Devices: Number Manufacturer / Model Natus VikingQuest K130346 Natus Neurology (Primary Incorporated Synergy… | 2013 |
| * | K120979 | Carefusion Nicolet EdxSummary page 4…Synergy Focus Laptop Version K120979 Carefusion 209, Inc. (Reference (now Natus Neurology… | 2012 |
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?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K130346.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP)…
Read the full statement (194 words)
The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).
Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.
The Natus VikingQuest is intended to be used by a qualified healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172743: Natus VikingQuest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172743
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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