510(k) · Cleared
ClearedSomnoMetry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neumetry Medical, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Sep 21, 2022 as substantially equivalent to K162627 (Ensodata, Inc., 2017) after a 149-day review. Its family tree reaches back 9 generations to 1997. 3 later devices descend from it.
- Decided
- Sep 21, 2022
- Review
- 149 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). 3 later devices descend from it, 1 citing it directly.
- 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 deviceK221179 SomnoMetryNeumetry Medical, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK241288 Noxturnal WebNox Medical Ehf · 2024
- Descendant · 2 generations on · 0 of its ownK261747 Report StudioBeacon Biosignals, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260585 Noxturnal WebNox Medical Ehf · 2026
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 deviceK221179 SomnoMetryNeumetry Medical, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView 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) | K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022 | — |
| +1 | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| +2 | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
| +2 | K260585 | Noxturnal Web | Nox Medical Ehf | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 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…882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLZ Review Panel: Neurology 3. Predicate Device EnsoData Inc., EnsoSleep K162627 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. 4. Device Des… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241288 | Noxturnal Web | 2024 | 2 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K241288 (Nox Medical Ehf, 2024) has gone furthest, with 2 descendants of its own.
- 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. 2022, 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?
SomnoMetry 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. SomnoMetry is a software-only medical device to be used to analyze physiological signals and automatically score sleep study results, including the staging of sleep, AHI, and detection of sleep-disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. All automatically scored events are subject to verification by a qualified clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221179 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221179: SomnoMetry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221179
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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