510(k) · Cleared
ClearedSOMNOscreen plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomedics GmbH · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Aug 12, 2020 as substantially equivalent to K040595 (Respironics, Inc., 2004) and 2 other predicates after a 113-day review. Its family tree reaches back 4 generations to 1997. 4 later devices descend from it.
- Decided
- Aug 12, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K962603 (1997). 15 ancestors in all, the oldest K930790 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- This deviceK201054 SOMNOscreen plusSomnomedics GmbH · 2020
- 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
- Descendant · cites it directly · 0 of its ownK240700 HomeSleepTest (HST, HST REM+)Somnomedics GmbH · 2024
Most influential descendants
Showing 4 of 4 · See all- K241288Noxturnal WebNox Medical Ehf · 2024 · cites it directly2descendants
- K261747Report StudioBeacon Biosignals, Inc. · 2026 · 2 generations on0descendants
- K260585Noxturnal WebNox Medical Ehf · 2026 · 2 generations on0descendants
- K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| 0 (this device) | K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020 | — |
| +1 | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| +2 | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
| +2 | K260585 | Noxturnal Web | Nox Medical Ehf | 2026 | — |
| +1 | K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 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 K241288 Noxturnal Webscore 17.3 · 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? (3)
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 |
|---|---|---|---|
| * | K040595 | ALICE 5Summary page 5…ver time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in 21 CFR 868.2377. Predicate Devices K040595 K071556 K060708 Alice® 5 System SOMNOscreen… | 2004 |
| * | K071556 | Somnoscreen EEG10-20Summary page 5…le alarm limits. This device does not include the apnea monitor classified in 21 CFR 868.2377. Predicate Devices K040595 K071556 K060708 Alice® 5 System SOMNOscreen EEG10-20 SOMNOmedics… | 2007 |
| * | K060708 | SomnoscreenSummary page 5…ice does not include the apnea monitor classified in 21 CFR 868.2377. Predicate Devices K040595 K071556 K060708 Alice® 5 System SOMNOscreen EEG10-20 SOMNOmedics… | 2007 |
What descends from it? (4)
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 23 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K241288 (Nox Medical Ehf, 2024) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K040595.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The SOMNOscreen® plus is a non-life-supporting portable physiological signal recording device intended to be used for testing adults and children (age 2 to 12 years)/adolescents (age 12 and above) suspected of having sleep-related breathing disorders.
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/K201054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201054: SOMNOscreen plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201054
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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