510(k) · Cleared
ClearedSleep Profiler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Brain Monitoring, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Mar 14, 2016 as substantially equivalent to K130007 (Advanced Brain Monitoring, Inc., 2013) after a 110-day review. Its family tree reaches back 7 generations to 1997. 13 later devices descend from it.
- Decided
- Mar 14, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962603 (1997). 33 ancestors in all, the oldest K873535 (1987). 13 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 4 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 3 generations backK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- 2 generations backK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- 1 generation backK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- This deviceK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- Descendant · cites it directly · 9 of its ownK162627 EnsoSleepEnsodata, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK221179 SomnoMetryNeumetry Medical, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK241288 Noxturnal WebNox Medical Ehf · 2024
- Descendant · 2 generations on · 1 of its ownK223922 Somnum (V.1.1.2.)Honeynaps Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK261747 Report StudioBeacon Biosignals, Inc. · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K162627EnsoSleepEnsodata, Inc. · 2017 · cites it directly9descendants
- K221179SomnoMetryNeumetry Medical, Inc. · 2022 · 2 generations on3descendants
- K241288Noxturnal WebNox Medical Ehf · 2024 · 3 generations on2descendants
- K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd. · 2023 · 2 generations on1descendant
- K261747Report StudioBeacon Biosignals, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −4 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −3 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| −2 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| −1 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| 0 (this device) | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| +1 | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
| +2 | K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022 | — |
| +3 | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| +2 | K223922 | Somnum (V.1.1.2.) | Honeynaps Co., Ltd. | 2023 | — |
| +4 | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K130007 | Sleep ProfilerSummary page 4…ograph, Automatic Event Detection Software For Polysomnograph With Electroencephalograph REVIEW PANEL: Neurology PRODUCT CODE: OLZ PREDICATE DEVICE(S): Sleep Profiler (K130007) Reference predicate device, Apnea Risk Evaluation System (ARES), Model 610 (K112514) A… | 2013 |
| † | K112514 | Apnea Risk Evaluation System (Ares) | 2012 |
What descends from it? (13)
See all 134 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 33 ancestors have a recall of any class.
- Of its descendants, K162627 (Ensodata, Inc., 2017) has gone furthest, with 9 descendants of its own.
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. 2016, 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?
Sleep Profiler is intended for use for the diagnostic evaluation by a physician to assess sleep quality and score sleep disordered breathing events in adults only. The Sleep Profiler is a software-only device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results; including the staging of sleep, detection of arousals, snoring and sleep disordered breathing events (obstructive apneas, hypopneas and respiratory event related arousals). Central and mixed apneas can be manually marked within the records.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153412: Sleep Profiler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153412
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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