510(k) · Cleared
ClearedNoxturnal Web
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nox Medical Ehf · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Dec 23, 2024 as substantially equivalent to K201054 (Somnomedics GmbH, 2020) and 1 other predicate after a 230-day review. Its family tree reaches back 10 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 23, 2024
- Review
- 230 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K962603 (1997). 42 ancestors in all, the oldest K873535 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- 2 generations backK162627 EnsoSleepEnsodata, Inc. · 2017
- 1 generation backK221179 SomnoMetryNeumetry Medical, Inc. · 2022
- This deviceK241288 Noxturnal WebNox Medical Ehf · 2024
- Descendant · cites it directly · 0 of its ownK261747 Report StudioBeacon Biosignals, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260585 Noxturnal WebNox Medical Ehf · 2026
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 7 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 6 generations backK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- 5 generations backK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- 4 generations backK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- 3 generations backK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- 2 generations backK162627 EnsoSleepEnsodata, Inc. · 2017
- 1 generation backK221179 SomnoMetryNeumetry Medical, Inc. · 2022
- This deviceK241288 Noxturnal WebNox Medical Ehf · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −7 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −6 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| −5 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| −4 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| −3 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| −2 | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
| −1 | K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022 | — |
| 0 (this device) | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| +1 | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
| +1 | 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 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OLV? 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 OLV device
- #1 K261747 Report Studioscore 14.9 · 11 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 |
|---|---|---|---|
| * | K201054 | SOMNOscreen plusSummary page 6…eurology PREDICATE DEVICE IDENTIFICATION Substantial equivalence is claimed to: Primary Predicate Device Somnomedics GmbH, SOMNOscreen plus, K201054 Additional Predicate Device Neumetry Medical Inc, SomnoMetry, K221179 Reference Device… | 2020 |
| * | K221179 | SomnoMetrySummary page 6…redicate Device Somnomedics GmbH, SOMNOscreen plus, K201054 Additional Predicate Device Neumetry Medical Inc, SomnoMetry, K221179 Reference Device Nox Medical, Nox Sleep System, K192469 All predicate and reference devices ha… | 2022 |
| † | K192469 | Nox Sleep System | 2019 |
What descends from it? (2)
2 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 27 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K261747 (Beacon Biosignals, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201054.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Noxturnal Web is intended to be used 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.
Noxturnal Web is a software-only medical device to be used to analyze physiological signals and manually 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.
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/K241288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241288: Noxturnal Web.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241288
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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