510(k) · Cleared
ClearedModius Sleep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovalens, Ltd. · QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Cleared on Oct 27, 2023 as substantially equivalent to K062284 (Neuro-Fitness, LLC, 2007) and 1 other predicate after a 217-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Oct 27, 2023
- Review
- 217 days
- Class
- Class II
- Product code
- QJQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883812 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883812 HP-1 (Healthpax)Healthdirections, Inc. · 1988 · Recalled
- 1 generation backK062284 Ces UltraNeuro-Fitness, LLC · 2007 · Recalled
- This deviceK230826 Modius SleepNeurovalens, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK252951 Genesis SleepNeurofield, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252951Genesis SleepNeurofield, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883812 | HP-1 (Healthpax) | Healthdirections, Inc. | 1988 | 1 |
| −1 | K062284 | Ces Ultra | Neuro-Fitness, LLC | 2007 | 1 |
| 0 (this device) | K230826 | Modius Sleep | Neurovalens, Ltd. | 2023 | — |
| +1 | K252951 | Genesis Sleep | Neurofield, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 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 QJQ? 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 QJQ device
- #1 K252951 Genesis Sleepscore 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K062284 | Ces UltraSummary page 6…Version: 01 Page: 2 of 30 510(k) Summary III. Predicate devices Primary predicate device CES Ultra, K062284 Secondary predicate device Alpha-Stim® CS, K903014 No reference devices were used in this submission. IV. Device descrip… | 2007 |
| * | K903014 | Alpha-Stim CSSummary page 6…f 30 510(k) Summary III. Predicate devices Primary predicate device CES Ultra, K062284 Secondary predicate device Alpha-Stim® CS, K903014 No reference devices were used in this submission. IV. Device description Modius Sleep is a low-risk non-invasive trans… | 1992 |
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 |
|---|---|---|---|
| K252951 | Genesis Sleep | 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 35 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K252951 (Neurofield, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062284.
How does its category compare?
All QJQ devicesQJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJQ
Too few QJQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QJQ
No recall names QJQ since 2007.
Adverse event reports per year · QJQ
39in 2023
MAUDE reports naming product code QJQ, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults aged 22 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230826: Modius Sleep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230826
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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