510(k) Report

510(k) · Cleared

Cleared

Neurometrix Advance

K070109510(k) TraditionalCleared Apr 25, 2008470-day reviewClass II21 CFR 882.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neurometrix, Inc. · JXE Device, Nerve Conduction Velocity Measurement

Cleared on Apr 25, 2008 as substantially equivalent to K944547 (Mckenna & Cuneo, 1995) and 3 other predicates after a 470-day review. Its family tree reaches back 5 generations to 1980. 15 later devices descend from it.

Decided
Apr 25, 2008
Review
470 days
Class
Class II
Product code
JXE
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K802637 (1980). 9 ancestors in all. 15 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestor2019: 1 descendant cleared2012: 1 descendant cleared2017: 2 descendants cleared2025: 2 descendants cleared2013: 1 descendant cleared2024: 1 descendant cleared2023: 3 descendants cleared2018: 1 descendant cleared2022: 2 descendants cleared2026: 1 descendant clearedK802637 · Teca Model-10 Electromyograph · Teca, Inc. · 1980K982359 · NC-Stat · Neurometrix, Inc. · 1998K013459 · Modification of NC-Stat · Neurometrix, Inc. · 2002K041320 · Modification to NC-Stat · Neurometrix, Inc. · 2004K060584 · NC-Stat · Neurometrix, Inc. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K060584 · NC-Stat · Neurometrix, Inc. · 2006K041320 · Modification to NC-Stat · Neurometrix, Inc. · 2004K013459 · Modification of NC-Stat · Neurometrix, Inc. · 2002K982359 · NC-Stat · Neurometrix, Inc. · 1998K802637 · Teca Model-10 Electromyograph · Teca, Inc. · 1980−50+5
  1. Root · 5 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
  2. 4 generations backK982359 NC-StatNeurometrix, Inc. · 1998
  3. 3 generations backK013459 Modification of NC-StatNeurometrix, Inc. · 2002
  4. 2 generations backK041320 Modification to NC-StatNeurometrix, Inc. · 2004
  5. 1 generation backK060584 NC-StatNeurometrix, Inc. · 2006
  6. This deviceK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
  7. Descendant · cites it directly · 12 of its ownK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
  8. Descendant · 2 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
  9. Descendant · 3 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
  10. Descendant · 2 generations on · 3 of its ownK130346 Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated · 2013
  11. Descendant · 3 generations on · 1 of its ownK243495 Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated · 2024

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12017: 22018: 12019: 12022: 22023: 32024: 12025: 22026: 1
2012high 3 (2023) · low 0 (2014)2026

Most influential descendants

Showing 5 of 15 · See all
  • K120979Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · cites it directly12descendants
  • K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 2 generations on7descendants
  • K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 3 generations on5descendants
  • K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated · 2013 · 2 generations on3descendants
  • K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K802637Teca Model-10 ElectromyographTeca, Inc.1980—
−4K982359NC-StatNeurometrix, Inc.1998—
−3K013459Modification of NC-StatNeurometrix, Inc.2002—
−2K041320Modification to NC-StatNeurometrix, Inc.2004—
−1K060584NC-StatNeurometrix, Inc.2006—
0 (this device)K070109Neurometrix AdvanceNeurometrix, Inc.2008—
+1K120979Carefusion Nicolet EdxCarefusion 209, Inc.2012—
+2K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.20173
+3K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH2022—
+2K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated2013—
+3K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199510
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201720
201810
201910
202220
202330
202410
202520
202610
FIG. 1 — Lineage of K070109, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240189 NM-01/CPT neurometer (NM-01/CPT)score 10.9 · 7 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K944547Dantec Keypoint
Summary page 1
…882.1550 JXE Nerve Conduction Velocity Measurement Device 3. PREDICATE DEVICES · Dantec Keypoint® (K944547) * NeuroMetrix NC-stat® (K060584, K041320, K013459) 4. INTENDED USE NeuroMetrix ADVANCE is intended to perform ne…
Mckenna & Cuneo19951
*K060584NC-Stat
Summary page 1
…locity Measurement Device 3. PREDICATE DEVICES · Dantec Keypoint® (K944547) * NeuroMetrix NC-stat® (K060584, K041320, K013459) 4. INTENDED USE NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle e…
Neurometrix, Inc.2006—
*K041320Modification to NC-Stat
Summary page 1
…Measurement Device 3. PREDICATE DEVICES · Dantec Keypoint® (K944547) * NeuroMetrix NC-stat® (K060584, K041320, K013459) 4. INTENDED USE NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyo…
Neurometrix, Inc.2004—
*K013459Modification of NC-Stat
Summary page 1
…Measurement Device 3. PREDICATE DEVICES · Dantec Keypoint® (K944547) * NeuroMetrix NC-stat® (K060584, K041320, K013459) 4. INTENDED USE NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyography pr…
Neurometrix, Inc.2002—

Also cleared against K944547: 3 other devices →

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212
K190536Mediracer NCSMediracer OY20191

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 28 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K120979 (Carefusion 209, Inc., 2012) has gone furthest, with 12 descendants of its own.
  • 3 other devices also cite its predicate K944547.

How does its category compare?

All JXE devices

JXE Device, Nerve Conduction Velocity Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · JXE

1in 2025

2008: 12019: 12025: 1
2007high 1 (2008) · low 0 (2007)2026

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

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXE

1in 2025

2007: 22008: 12009: 32011: 52012: 62013: 52014: 62015: 42016: 52017: 122018: 82019: 12024: 12025: 1
2007high 12 (2017) · low 0 (2010)2025

MAUDE reports naming product code JXE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20081—01
20090—03
20100—00
20110—05
20120—16
20130—05
20140—06
20150—04
20160—05
20170—012
20180—08
20191—01
20200—00
20210—00
20220—00
20230—00
20240—01
20251—01
20260—0—

What is it indicated for?

NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyography procedures. As such, NeuroMetrix ADVANCE is intended to measure neuromuscular signals that are useful as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. If the elective needle EMG module is used, then the device is also intended to measure signals that are useful as an aid in evaluating disorders of muscles.

This device must be used in the context of other patient information. Its output must be reviewed and interpreted by a physician who will exercise professional judgment when using this information.

Indications for use as stated in the FDA summary.

Also cleared against K944547

3 other devices cite the same predicate.

  • K091940Magpro, Models R30 with Magoption, X100, X100 with MagoptionTonica Elektronik A/S · 2010
  • K082614Evox Electro Diagnostic DeviceLaborie Medical Technologies, Inc. · 2009
  • K992715Neuro Urodynamic Suite, Model 9032E0101Medtronic Functional Diagnostics A/S · 2000

More from Neurometrix, Inc.

18 FDA decisions under this applicant name. See the company

  • DEN210046Quell-FMNeurometrix, Inc. · 2022
  • K152954QuellNeurometrix, Inc. · 2016
  • K140586Ascend ElectrodeNeurometrix, Inc. · 2014
  • K140333AscendNeurometrix, Inc. · 2014
  • K130919SensusNeurometrix, Inc. · 2013

Recent decisions in JXE

The JXE category page

  • K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto, · 2025
  • K190536Mediracer NCSMediracer OY · 2019
  • K060584NC-StatNeurometrix, Inc. · 2006
  • K053058Xltek Neuropath, Model PK1070Excel Tech., Ltd. · 2006
  • K052904Virtual Medical Systems Model VT3000Scientific Imaging, Inc. · 2005

https://510kreport.com/device/K070109 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070109: Neurometrix Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070109

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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