510(k) · Cleared
ClearedAlpha-Stim CS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electromedical Products, Inc. · QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Cleared on May 12, 1992 after a 672-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 12, 1992
- Review
- 672 days
- Class
- Class II
- Product code
- QJQ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK903014 Alpha-Stim CSElectromedical Products, Inc. · 1992
- Descendant · cites it directly · 1 of its ownK230826 Modius SleepNeurovalens, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252951 Genesis SleepNeurofield, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232253 Modius StressNeurovalens Limited · 2024
- Descendant · cites it directly · 0 of its ownK182311 CervellaInnovative Neurological Devices, LLC · 2019
- Descendant · cites it directly · 0 of its ownK060158 Net-2000 Microcurrent StimulatorAuri-Stem Medical, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K230826Modius SleepNeurovalens, Ltd. · 2023 · cites it directly1descendant
- K252951Genesis SleepNeurofield, Inc. · 2025 · 2 generations on0descendants
- K232253Modius StressNeurovalens Limited · 2024 · cites it directly0descendants
- K182311CervellaInnovative Neurological Devices, LLC · 2019 · cites it directly0descendants
- K060158Net-2000 Microcurrent StimulatorAuri-Stem Medical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903014 | Alpha-Stim CS | Electromedical Products, Inc. | 1992 | — |
| +1 | K230826 | Modius Sleep | Neurovalens, Ltd. | 2023 | — |
| +2 | K252951 | Genesis Sleep | Neurofield, Inc. | 2025 | — |
| +1 | K232253 | Modius Stress | Neurovalens Limited | 2024 | — |
| +1 | K182311 | Cervella | Innovative Neurological Devices, LLC | 2019 | — |
| +1 | K060158 | Net-2000 Microcurrent Stimulator | Auri-Stem Medical, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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
- #3 Held for the reportin 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? (5)
4 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, K230826 (Neurovalens, Ltd., 2023) has gone furthest, with 1 descendant of its own.
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.
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 | — |
https://510kreport.com/device/K903014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903014: Alpha-Stim CS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903014
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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