510(k) · Cleared
ClearedMediracer NCS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediracer OY · JXE Device, Nerve Conduction Velocity Measurement
Cleared on Sep 25, 2019 as substantially equivalent to K070109 (Neurometrix, Inc., 2008) after a 205-day review. Its family tree reaches back 6 generations to 1980. 1 later device descends from it.
- Decided
- Sep 25, 2019
- Review
- 205 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K802637 (1980). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 5 generations backK982359 NC-StatNeurometrix, Inc. · 1998
- 4 generations backK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- 3 generations backK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- 2 generations backK060584 NC-StatNeurometrix, Inc. · 2006
- 1 generation backK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
- This deviceK190536 Mediracer NCSMediracer OY · 2019
- Descendant · cites it directly · 0 of its ownK240189 NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto, · 2025
Most influential descendants
Showing 1 of 1 · See all- K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto, · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| −5 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| −4 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| −3 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| −2 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| −1 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
| 0 (this device) | K190536 | Mediracer NCS | Mediracer OY | 2019 | — |
| +1 | K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 JXE? 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 JXE device
- #1 K240189 NM-01/CPT neurometer (NM-01/CPT)score 10.9 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K070109 | Neurometrix AdvanceSummary page 4…e Class: Device Class II (21 CFR 882.1550) Product Code: JXE Predicate device NeuroMetrix ADVANCE K070109 1 DEVICE DESCRIPTION The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves, when t… | 2008 |
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 |
|---|---|---|---|
| K240189 | NM-01/CPT neurometer (NM-01/CPT) | 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 39 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K240189 (Mde Orvosbiológiai Kutató, Fejleszto,, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070109.
How does its category compare?
All JXE devicesJXE Device, Nerve Conduction Velocity Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JXE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXE
Too few JXE 510(k)s in any year since 2007 to give a median.
Recalls per year · JXE
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXE
1in 2025
MAUDE reports naming product code JXE, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 1 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190536: Mediracer NCS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190536
Report an extraction error
Are you the manufacturer?
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