510(k) · Cleared
ClearedSomnoscreen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomedics GmbH & Co. KG · MNR Ventilatory Effort Recorder
Cleared on Jan 24, 2007 as substantially equivalent to K021138 (Erich Jaeger GmbH, 2003) and 1 other predicate after a 314-day review. Its family tree reaches back 2 generations to 2000. 11 later devices descend from it.
- Decided
- Jan 24, 2007
- Review
- 314 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000396 (2000). 3 ancestors in all, the oldest K003175 (2000). 11 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK000396 Apnoescreen Pro, Alpha Screen ProErich Jaeger, Inc. · 2000
- 1 generation backK021138 Sleepscreen/Apnoescreen CardioErich Jaeger GmbH · 2003
- This deviceK060708 SomnoscreenSomnomedics GmbH & Co. KG · 2007
- Descendant · cites it directly · 5 of its ownK071556 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 · cites it directly · 1 of its ownK103631 Sleepminder Breathing Frequency IndicatorBiancamed Limited · 2011
- Descendant · 3 generations on · 0 of its ownK261747 Report StudioBeacon Biosignals, Inc. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K071556Somnoscreen EEG10-20Somnomedics GmbH · 2007 · cites it directly5descendants
- K201054SOMNOscreen plusSomnomedics GmbH · 2020 · cites it directly4descendants
- K241288Noxturnal WebNox Medical Ehf · 2024 · 2 generations on2descendants
- K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited · 2011 · cites it directly1descendant
- K261747Report StudioBeacon Biosignals, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000396 | Apnoescreen Pro, Alpha Screen Pro | Erich Jaeger, Inc. | 2000 | — |
| −1 | K021138 | Sleepscreen/Apnoescreen Cardio | Erich Jaeger GmbH | 2003 | — |
| 0 (this device) | K060708 | Somnoscreen | Somnomedics GmbH & Co. KG | 2007 | — |
| +1 | K071556 | Somnoscreen EEG10-20 | Somnomedics GmbH | 2007 | — |
| +1 | K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020 | — |
| +2 | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| +1 | K103631 | Sleepminder Breathing Frequency Indicator | Biancamed Limited | 2011 | — |
| +3 | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K021138 | Sleepscreen/Apnoescreen CardioSummary page 1…H & Co.KG Nonnengarten 8 Kist, Germany D-97270 Predicate Devices: SleepSereen/ApnoeScreen Cardio (K021138), Compumedics Siesta System (K003175) Device Description: The SOMNOscreen is a port… | 2003 |
| * | K003175 | Compumedics Siesta SystemSummary page 1…Kist, Germany D-97270 Predicate Devices: SleepSereen/ApnoeScreen Cardio (K021138), Compumedics Siesta System (K003175) Device Description: The SOMNOscreen is a portable physiological signal recording system intended to be used to r… | 2000 |
What descends from it? (11)
See all 116 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 7 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071556 (Somnomedics GmbH, 2007) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K021138.
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 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/K060708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060708: Somnoscreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060708
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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