510(k) · Cleared
ClearedSomnoscreen EEG10-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomedics GmbH · MNR Ventilatory Effort Recorder
Cleared on Jul 18, 2007 as substantially equivalent to K060708 (Somnomedics GmbH & Co. KG, 2007) after a 41-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.
- Decided
- Jul 18, 2007
- Review
- 41 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000396 (2000). 4 ancestors in all, the oldest K003175 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK000396 Apnoescreen Pro, Alpha Screen ProErich Jaeger, Inc. · 2000
- 2 generations backK021138 Sleepscreen/Apnoescreen CardioErich Jaeger GmbH · 2003
- 1 generation backK060708 SomnoscreenSomnomedics GmbH & Co. KG · 2007
- This deviceK071556 Somnoscreen EEG10-20Somnomedics GmbH · 2007
- Descendant · cites it directly · 4 of its ownK201054 SOMNOscreen plusSomnomedics GmbH · 2020
- Descendant · 2 generations on · 2 of its ownK241288 Noxturnal WebNox Medical Ehf · 2024
- Descendant · 3 generations on · 0 of its ownK261747 Report StudioBeacon Biosignals, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK260585 Noxturnal WebNox Medical Ehf · 2026
- Descendant · 2 generations on · 0 of its ownK240700 HomeSleepTest (HST, HST REM+)Somnomedics GmbH · 2024
Most influential descendants
Showing 5 of 5 · See all- K201054SOMNOscreen plusSomnomedics GmbH · 2020 · cites it directly4descendants
- K241288Noxturnal WebNox Medical Ehf · 2024 · 2 generations on2descendants
- K261747Report StudioBeacon Biosignals, Inc. · 2026 · 3 generations on0descendants
- K260585Noxturnal WebNox Medical Ehf · 2026 · 3 generations on0descendants
- K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000396 | Apnoescreen Pro, Alpha Screen Pro | Erich Jaeger, Inc. | 2000 | — |
| −2 | K021138 | Sleepscreen/Apnoescreen Cardio | Erich Jaeger GmbH | 2003 | — |
| −1 | K060708 | Somnoscreen | Somnomedics GmbH & Co. KG | 2007 | — |
| 0 (this device) | K071556 | Somnoscreen EEG10-20 | Somnomedics GmbH | 2007 | — |
| +1 | K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020 | — |
| +2 | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| +3 | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
| +3 | K260585 | Noxturnal Web | Nox Medical Ehf | 2026 | — |
| +2 | K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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 MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 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 |
|---|---|---|---|
| * | K060708 | SomnoscreenSummary page 2…of Nonclinical Testing: The SOMNOscreen EEGIO-20 was subject to the same preclinical requirements as the previously cleared predicate device the Somnomedics SOMNOscreen (K060708). Performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as d… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201054 | SOMNOscreen plus | 2020 | 4 |
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 7 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K201054 (Somnomedics GmbH, 2020) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K060708.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
The SOMNOscreen UEGIO20 is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071556 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071556: Somnoscreen EEG10-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071556
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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