510(k) · Cleared
ClearedNatus Ultrapro S100 (982A0594)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Neurology Incorporated · GWF Stimulator, Electrical, Evoked Response
Cleared on Dec 12, 2024 as substantially equivalent to K130346 (Natus Neurology Incorporated, 2013) and 1 other predicate after a 30-day review. Its family tree reaches back 8 generations to 1980. 1 later device descends from it.
- Decided
- Dec 12, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K802637 (1980). 27 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK243495 Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated · 2024
- Descendant · cites it directly · 0 of its ownK243982 Nicolet EDXNatus Neurology Incorporated · 2025
Most influential descendants
Showing 1 of 1 · See all- K243982Nicolet EDXNatus Neurology Incorporated · 2025 · cites it directly0descendants
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) | K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024 | — |
| +1 | K243982 | Nicolet EDX | Natus Neurology Incorporated | 2025 | — |
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 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 5…21CFR §882.1900 GWE 21CFR §882.1890 GZP 21CFR §882.1880 Predicate Devices: K130346 Synergy Focus (Primary Predicate) K162383 Cadwell Sierra Summit, Cadwell Sierra Ascent… | 2013 |
| * | K162383 | Cadwell Sierra Summit, Cadwell Sierra AscentSummary page 5…1890 GZP 21CFR §882.1880 Predicate Devices: K130346 Synergy Focus (Primary Predicate) K162383 Cadwell Sierra Summit, Cadwell Sierra Ascent Natus Neurology Incorporated | 3150 Pleasant View Road, Middleton, WI 5… | 2017 |
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 |
|---|---|---|---|
| K243982 | Nicolet EDX | 2025 | 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?
- The line of descent spans 44 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K243982 (Natus Neurology Incorporated, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130346.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The UltraPro 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 Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP)…
Read the full statement (202 words)
The UltraPro 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 Potentials (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 UltraPro with
Natus Elite Software 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 UltraPro with Natus Elite Software 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 UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.
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/K243495 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243495: Natus Ultrapro S100 (982A0594).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243495
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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