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 Jun 16, 2021 as substantially equivalent to K162627 (Ensodata, Inc., 2017) after a 161-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Jun 16, 2021
- Review
- 161 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962603 (1997). 35 ancestors in all, the oldest K873535 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- 2 generations backK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- 1 generation backK162627 EnsoSleepEnsodata, Inc. · 2017
- This deviceK210034 EnsoSleepEnsodata, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 6 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 5 generations backK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- 4 generations backK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- 3 generations backK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- 2 generations backK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- 1 generation backK162627 EnsoSleepEnsodata, Inc. · 2017
- This deviceK210034 EnsoSleepEnsodata, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −6 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −5 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| −4 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| −3 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| −2 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| −1 | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
| 0 (this device) | K210034 | EnsoSleep | Ensodata, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K162627 | EnsoSleepSummary page 4…alified clinician. All events can be manually marked or edited within records during review. Target Patient Population: Adult and Pediatric III. PREDICATE DEVICE K162627 Trade Name: EnsoSleep Target Patient Population: Adults only… | 2017 |
| † | K112102 | Michele Sleep Scoring Systems | 2011 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 35 ancestors have a recall of any class.
- 4 other devices also cite its predicate K162627.
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. 2021, 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 in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric and adult patients as follows: * Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic * Adult patients with PSGs obtained in a Hospital or Sleep Clinic * Adult patients with Home Sleep…
Read the full statement (225 words)
EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric and adult patients as follows:
* Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic
* Adult patients with PSGs obtained in a Hospital or Sleep Clinic
* Adult patients with Home Sleep Tests
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 (OSA), central sleep apneas (CSA), and hypopneas.
All automatically scored events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician. Central sleep apneas (CSA) should be manually reviewed and modified as appropriate by a clinician.
All events can be manually marked or edited within records during review.
Photoplethysmography (PPG) total sleep time is not intended for use when electroencephalograph (EEG) data is recorded.
PPG total sleep time is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210034: EnsoSleep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210034
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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