510(k) · Cleared
ClearedGenesis Sleep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurofield, Inc. · QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Cleared on Dec 31, 2025 as substantially equivalent to K230826 (Neurovalens, Ltd., 2023) after a 106-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Dec 31, 2025
- Review
- 106 days
- Class
- Class II
- Product code
- QJQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883812 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883812 | HP-1 (Healthpax) | Healthdirections, Inc. | 1988 | 1 |
| −2 | K062284 | Ces Ultra | Neuro-Fitness, LLC | 2007 | 1 |
| −1 | K230826 | Modius Sleep | Neurovalens, Ltd. | 2023 | — |
| 0 (this device) | 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 |
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 K230826 Modius Sleepscore 9.5 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K230826 | Modius SleepSummary page 5…ame: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety Regulation Number: 882.5800 Product Code: QJQ Legally Marketed Predicate Devices 510(k) Number: K230826 Device Name: Modius Sleep Product Code: QJQ Device Description Summary Genesis Sleep is a non-invasive transdermal neurostimula… | 2023 |
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?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 16.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2025, 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?
Genesis Sleep is a non-invasive, clinical- and 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/K252951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252951: Genesis Sleep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252951
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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