510(k) · Cleared
ClearedMedi-DX 7000 CPT with Amrex Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro-Diagnostic Assoc. · GWF Stimulator, Electrical, Evoked Response
Cleared on May 20, 1998 as substantially equivalent to K853608 (Neurotron, Inc., 1986) after a 90-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- May 20, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853608 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK853608 NeurometerNeurotron, Inc. · 1986
- This deviceK980866 Medi-DX 7000 CPT with Amrex ElectrodesNeuro-Diagnostic Assoc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853608 | Neurometer | Neurotron, Inc. | 1986 | — |
| 0 (this device) | K980866 | Medi-DX 7000 CPT with Amrex Electrodes | Neuro-Diagnostic Assoc. | 1998 | — |
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? (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 |
|---|---|---|---|
| * | K853608 | NeurometerSummary page 1…7-8437 Contact person: Dr. James L. Hedgecock Date Submitted: 11/06/97 Name of Device: Medi-Dx 7000 510 (k) 964622 Equivalent Device: Neurometer by Neurotron; 510(k) 853608 This Summary is the same as the previously accepted one with the exception of the inclusion of the AMREX electrodes mentioned in… | 1986 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K853608.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Medi-Dx 7000 is a diagnostic device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used for diagnostic purposes would include any Individual capable of communicating their perception of cutaneous sensation.
The Medi-Dx 7000 diagnostic examination may be conducted as part of 2 routine neurological examination or as a screening procedure for the detection of peripheral neuropathy which may be caused by various pathological conditions or exposures to toxic substances.
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/K980866 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980866: Medi-DX 7000 CPT with Amrex Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980866
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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