510(k) · Cleared
ClearedSomniCheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainmatterz, LLC · GWL Amplifier, Physiological Signal
Cleared on Jun 1, 2023 as substantially equivalent to K040113 (Eb Neuro S.P.A., 2004) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jun 1, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003154 (2001). 4 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 |
|---|---|---|---|---|---|
| −2 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −1 | K040113 | Sandman SD20 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| 0 (this device) | K223676 | SomniCheck | Brainmatterz, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2022 | 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 GWL? 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 GWL device
- #1 K232210 X-trodes System Mscore 10.4 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K040113 | Sandman SD20 AmplifierSummary page 4…sification Name: Amplifier, Physiological Signal Regulation Number: 882.1835 Product Code: GWL Predicate Device (a)(3) Primary Predicate Device: Sandman SD20 Amplifier (K040113, Product Code GWL) Secondary Predicate Device: NomadAir PMU810 (K220631, Product Code GWL) Device Description (a)(4) SomniCheck… | 2004 |
| * | K220631 | NomadAir PMU810Summary page 4…1835 Product Code: GWL Predicate Device (a)(3) Primary Predicate Device: Sandman SD20 Amplifier (K040113, Product Code GWL) Secondary Predicate Device: NomadAir PMU810 (K220631, Product Code GWL) Device Description (a)(4) SomniCheck is an integrated single-use disposable physiological data recorder inten… | 2022 |
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 22 years and passes through 2 companies; a new generation was cleared every 19.3 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K040113.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, 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 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SomniCheck is a prescription-use, single use physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems. The device measures the following signals:
• EEG (4-channel),
• PPG (by Maxim),
• Temperature,
• 3-axis accelerometer,
• Gyroscope (position), and
• Audio/ sound for snoring.
It is intended for use on adult patients (18 and older) and can be used in a hospital, clinic, or home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223676: SomniCheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223676
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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