510(k) · Cleared
ClearedNeurometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotron, Inc. · LLN Device, Vibration Threshold Measurement
Cleared on Jun 12, 1986 after a 288-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Jun 12, 1986
- Review
- 288 days
- Class
- Class I
- Product code
- LLN
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 4 citing it directly.
- This deviceK853608 NeurometerNeurotron, Inc. · 1986
- Descendant · cites it directly · 21 of its ownK982359 NC-StatNeurometrix, Inc. · 1998
- Descendant · 2 generations on · 20 of its ownK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- Descendant · 2 generations on · 19 of its ownK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- Descendant · 2 generations on · 18 of its ownK060584 NC-StatNeurometrix, Inc. · 2006
- Descendant · 3 generations on · 15 of its ownK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K982359NC-StatNeurometrix, Inc. · 1998 · cites it directly21descendants
- K013459Modification of NC-StatNeurometrix, Inc. · 2002 · 2 generations on20descendants
- K041320Modification to NC-StatNeurometrix, Inc. · 2004 · 2 generations on19descendants
- K060584NC-StatNeurometrix, Inc. · 2006 · 2 generations on18descendants
- K070109Neurometrix AdvanceNeurometrix, Inc. · 2008 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853608 | Neurometer | Neurotron, Inc. | 1986 | — |
| +1 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| +2 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| +2 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| +2 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| +3 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 254 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?
- Of its descendants, K982359 (Neurometrix, Inc., 1998) has gone furthest, with 21 descendants of its own.
How does its category compare?
All LLN devicesLLN Device, Vibration Threshold Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LLN
Too few LLN 510(k)s in any year since 2007 to give a median.
Recalls per year · LLN
No recall names LLN since 2007.
Adverse event reports per year · LLN
No MAUDE report names LLN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K853608 · printed Nov 5, 2026
Cite this page
510(k) Report. “K853608: Neurometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K853608
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026