510(k) · Cleared
ClearedCarefusion Nicolet Edx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 209, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Mar 15, 2012 as substantially equivalent to K890495 (Nicolet Instrument Corp., 1989) and 6 other predicates after a 241-day review. Its family tree reaches back 3 generations to 1993. 30 later devices descend from it.
- Decided
- Mar 15, 2012
- Review
- 241 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K922488 (1993). 13 ancestors in all, the oldest K874685 (1988). 30 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK922488 Phasis ElectromyographBiosound, Inc. · 1993
- 2 generations backK073415 Nemus System; Nemus PC PeripheralEb Neuro S.P.A. · 2008
- 1 generation backK102610 Focus Emg DeviceTeleemg, LLC USA · 2011
- This deviceK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · cites it directly · 12 of its ownK162383 Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017
- Descendant · cites it directly · 12 of its ownK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 2 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · cites it directly · 7 of its ownK141316 Cognision Eeg/EP SystemNeuronetrix Solutions · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017 · cites it directly12descendants
- K120979Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · cites it directly12descendants
- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · 2 generations on9descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 2 generations on7descendants
- K141316Cognision Eeg/EP SystemNeuronetrix Solutions · 2015 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922488 | Phasis Electromyograph | Biosound, Inc. | 1993 | — |
| −2 | K073415 | Nemus System; Nemus PC Peripheral | Eb Neuro S.P.A. | 2008 | — |
| −1 | K102610 | Focus Emg Device | Teleemg, LLC USA | 2011 | — |
| 0 (this device) | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +1 | K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017 | — |
| +1 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +2 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +2 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +1 | K141316 | Cognision Eeg/EP System | Neuronetrix Solutions | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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.
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? (7)
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 |
|---|---|---|---|
| * | K890495 | Nicolet Viking II SystemSummary page 1…21 CFR §882.1880 3. Predicate Devices 510(K) Device Name Number K890495 CareFusion Viking 11System K965065 CareFusion Synergy Mobile System… | 1989 |
| * | K965065 | Teca. MillenniumSummary page 1…ce Name Number K890495 CareFusion Viking 11System K965065 CareFusion Synergy Mobile System K984052 CareFUSion Synergy IOM System… | 1997 |
| * | K984052 | Synergy Iom SystemSummary page 1…K890495 CareFusion Viking 11System K965065 CareFusion Synergy Mobile System K984052 CareFUSion Synergy IOM System K991054 CareFusion Bravo Multi-Modality System 5 1… | 1999 |
| * | K991054 | Bravo Multi-Modality SystemSummary page 1…K965065 CareFusion Synergy Mobile System K984052 CareFUSion Synergy IOM System K991054 CareFusion Bravo Multi-Modality System 5 10(k) KI 12052, CareFusion Nicolet EDX with Viking Software… | 1999 |
| * | K102610 | Focus Emg DeviceSummary page 2…ality System 5 10(k) KI 12052, CareFusion Nicolet EDX with Viking Software Page 1 of 19 K102610 TeleEMO Focus EMG K924723 Cadwell Sierra Wave System… | 2011 |
| * | K924723 | Cadwell SierraSummary page 2…ware Page 1 of 19 K102610 TeleEMO Focus EMG K924723 Cadwell Sierra Wave System K010590 Nihon Kohden Micro System 4. Device… | 1993 |
| * | K010590 | Neuropack Micro, Model Med-9100A SeriesSummary page 2…K102610 TeleEMO Focus EMG K924723 Cadwell Sierra Wave System K010590 Nihon Kohden Micro System 4. Device Description The CareFusion Nicolet EDX system with Viking Software (Vi… | 2001 |
| † | K921927 | Nicolet Voyageur | 1992 |
What descends from it? (30)
See all 304 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K162383 (Cadwell Industries, Inc., 2017) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K890495.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Care~usion Nicolet EDX is attended for the acquisition- display. analysis. storage. reportng- and mannagement of elecaroplwsiolo-zical information from th# human nervous and muscular systems including Nerve Conduction QNCS%- Electromyozraphy (BMG). Evoked Potentials (EP). Autonomaic Responses and Intra-Operadive Monitoring including Electroencephalographv- (BEG). Evoked Potential (EP') includes Visual Evoked Potentials (VEP). Auditory Evoked…
Read the full statement (199 words)
The Care~usion Nicolet EDX is attended for the acquisition- display. analysis. storage. reportng- and mannagement of
elecaroplwsiolo-zical information from th# human nervous and muscular systems including Nerve Conduction QNCS%-
Electromyozraphy (BMG). Evoked Potentials (EP). Autonomaic Responses and Intra-Operadive Monitoring including
Electroencephalographv- (BEG).
Evoked Potential (EP') includes Visual Evoked Potentials (VEP). Auditory Evoked Potentials (ABEP), Somatosensorv,
Evoked Potentials (SEP), Electroreinogzraphy (ER.G> Electrooculographv (BOG). P300, Motor Evoked Potentials (NFfi).
The Nicolet EDX wvith Viking Softare may be used to detenmine autonomic responses to physiologic stimuli by measurngw
the change in electrical resistance between two electodes (Galvanic Skin Response and Sympathetic Skin Response).
Autonomic testine also includes assessment of FTR Interval variability. The Nicolet EDX wNith Viking Softwvare is used to
detect the physioioaic function of the nervous system, for the location of neural structures during surger)-. and to support
the diaynosis of neuromuscular disease or condition-
The isted modalities do include overlap in functionality- In general. Nerve Conduction Studies measure the electrial
responses of the nerve; Electromyography measures the electracal achavitv of the muscle and Evoked Potentials measure
electrical activity from the Central Nervous System.
The Nicolet EDX with Viking Softwvare is intended to be used by a qualified healthlcare 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/K112052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112052: Carefusion Nicolet Edx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112052
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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