510(k) · Cleared
ClearedEnsoSleep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ensodata, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Mar 31, 2017 as substantially equivalent to K153412 (Advanced Brain Monitoring, Inc., 2016) after a 192-day review. Its family tree reaches back 8 generations to 1997. 9 later devices descend from it.
- Decided
- Mar 31, 2017
- Review
- 192 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). 9 later devices descend from it, 5 citing it directly.
- 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 deviceK162627 EnsoSleepEnsodata, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK221179 SomnoMetryNeumetry Medical, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK241288 Noxturnal WebNox Medical Ehf · 2024
- Descendant · cites it directly · 1 of its ownK223922 Somnum (V.1.1.2.)Honeynaps Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK261747 Report StudioBeacon Biosignals, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253390 Somnum (Somnum)Honeynaps Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K221179SomnoMetryNeumetry Medical, Inc. · 2022 · cites it directly3descendants
- K241288Noxturnal WebNox Medical Ehf · 2024 · 2 generations on2descendants
- K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd. · 2023 · cites it directly1descendant
- K261747Report StudioBeacon Biosignals, Inc. · 2026 · 3 generations on0descendants
- K253390Somnum (Somnum)Honeynaps Co., Ltd. · 2026 · 2 generations on0descendants
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) | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
| +1 | K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022 | — |
| +2 | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| +1 | K223922 | Somnum (V.1.1.2.) | Honeynaps Co., Ltd. | 2023 | — |
| +3 | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
| +2 | K253390 | Somnum (Somnum) | Honeynaps Co., Ltd. | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 4…e: OLZ Regulatory Class: II (21 C.F.R. 882.1400) Review Panel: Neurology Predicate Device: Advanced Brain Monitoring, Inc. Sleep Profiler (K153412) Reference Device: Younes Sleep Technologies MICHELE Sleep Scoring System (K112102) Device Description: EnsoSlee… | 2016 |
| † | K112102 | Michele Sleep Scoring Systems | 2011 |
What descends from it? (9)
5 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 20 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 34 ancestors have a recall of any class.
- Of its descendants, K221179 (Neumetry Medical, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 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. 2017, 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?
EnsoSleep is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory related sleep disorders in adults only. EnsoSleep is a software-only medical 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, leg movements, and sleep disordered breathing events including obstructive apneas. All automatically scored events are subject to verification by a qualified clinician. Central apneas, mixed apneas, and hypopneas must be manually marked within records.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162627: EnsoSleep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162627
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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