510(k) · Cleared
ClearedSomnum (V.1.1.2.)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Honeynaps Co., Ltd. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Aug 16, 2023 as substantially equivalent to K162627 (Ensodata, Inc., 2017) and 1 other predicate after a 229-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Aug 16, 2023
- Review
- 229 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K962603 (1997). 35 ancestors in all, the oldest K873535 (1987). 1 later device descends 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 deviceK223922 Somnum (V.1.1.2.)Honeynaps Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253390 Somnum (Somnum)Honeynaps Co., Ltd. · 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 deviceK223922 Somnum (V.1.1.2.)Honeynaps Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K253390Somnum (Somnum)Honeynaps Co., Ltd. · 2026 · cites it directly0descendants
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) | K223922 | Somnum (V.1.1.2.) | Honeynaps Co., Ltd. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 2026 | 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? (2)
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 5…Name with Electroencephalograph Review Panel Neurology Ⅲ. PREDICATE DEVICE 510(k) Number K162627 Applicant ENSODATA Device Name EnsoSleep Regulation Number 21 CFR 882.1400… | 2017 |
| * | K112102 | Michele Sleep Scoring SystemsSummary page 6…with Electroencephalograph 2 510(k) Number K112102 Applicant YOUNES SLEEP TECHNOLOGIES Device Name MICHELE SLEEP SCORING SYSTEM Regulation Num… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253390 | Somnum (Somnum) | 2026 | 0 |
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 26 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, K253390 (Honeynaps Co., Ltd., 2026) has gone furthest, with 0 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. 2023, 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?
SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize and reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a…
Read the full statement (120 words)
SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize and reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.
For respiratory events - Sleep Disordered Breathing (Apneas and Hypopneas)- obstructive, central, mixed apneas, and hypopneas must be manually scored by physician. The device does not output specific apnea or hypopnea events and therefore should not be used for management decisions.
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/K223922 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223922: Somnum (V.1.1.2.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223922
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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