510(k) · Cleared
ClearedSleepStageML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beacon Biosignals, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Mar 8, 2024 as substantially equivalent to K153412 (Advanced Brain Monitoring, Inc., 2016) after a 147-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Mar 8, 2024
- Review
- 147 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962603 (1997). 34 ancestors in all, the oldest K873535 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 5 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 4 generations backK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- 3 generations backK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- 2 generations backK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- 1 generation backK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- This deviceK233438 SleepStageMLBeacon Biosignals, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −5 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −4 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| −3 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| −2 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| 0 (this device) | K233438 | SleepStageML | Beacon Biosignals, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 OLZ? 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 OLZ device
- #1 K253390 Somnum (Somnum)score 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K153412 | Sleep ProfilerSummary page 5…Trade Name: SleepStageML Common Name: SleepStageML Product Code: OLZ Regulatory Class: II (21 C.F.R. 882.1400) Review Panel: Neurology Predicate Device: Sleep Profiler (K153412, Advanced Brain Monitoring, Inc.) Reference Device: SomnoMetry (K221179, Neumetry Medical Inc.) Device description SleepStageML… | 2016 |
| † | K221179 | SomnoMetry | 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 27 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 34 ancestors have a recall of any class.
- 3 other devices also cite its predicate K153412.
How does its category compare?
All OLZ devicesOLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OLZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLZ
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLZ
No recall names OLZ since 2007.
Adverse event reports per year · OLZ
3in 2025
MAUDE reports naming product code OLZ, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 122 | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 4 | 185 | 0 | 3 |
| 2026 | 3 | 155 | 0 | — |
What is it indicated for?
SleepStageML is intended for assisting the diagnostic evaluation by a qualified clinician to assess sleep quality from level 1 polysomnography (PSG) recordings in a clinical environment in patients aged 18 and older.
SleepStageML is a software-only medical device to be used to analyze physiological signals and automatically score sleep stages. All outputs are subject to review by a qualified clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233438: SleepStageML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233438
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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