510(k) · Cleared
ClearedApnoescreen Pro, Alpha Screen Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erich Jaeger, Inc. · MNR Ventilatory Effort Recorder
Cleared on Dec 27, 2000 after a 324-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.
- Decided
- Dec 27, 2000
- Review
- 324 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK000396 Apnoescreen Pro, Alpha Screen ProErich Jaeger, Inc. · 2000
- Descendant · cites it directly · 17 of its ownK021138 Sleepscreen/Apnoescreen CardioErich Jaeger GmbH · 2003
- Descendant · 2 generations on · 11 of its ownK060708 SomnoscreenSomnomedics GmbH & Co. KG · 2007
- Descendant · 3 generations on · 5 of its ownK071556 Somnoscreen EEG10-20Somnomedics GmbH · 2007
- Descendant · 3 generations on · 4 of its ownK201054 SOMNOscreen plusSomnomedics GmbH · 2020
- Descendant · 2 generations on · 4 of its ownK051907 InnocorInnovision A/S · 2006
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K021138Sleepscreen/Apnoescreen CardioErich Jaeger GmbH · 2003 · cites it directly17descendants
- K060708SomnoscreenSomnomedics GmbH & Co. KG · 2007 · 2 generations on11descendants
- K071556Somnoscreen EEG10-20Somnomedics GmbH · 2007 · 3 generations on5descendants
- K201054SOMNOscreen plusSomnomedics GmbH · 2020 · 3 generations on4descendants
- K051907InnocorInnovision A/S · 2006 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000396 | Apnoescreen Pro, Alpha Screen Pro | Erich Jaeger, Inc. | 2000 | — |
| +1 | K021138 | Sleepscreen/Apnoescreen Cardio | Erich Jaeger GmbH | 2003 | — |
| +2 | K060708 | Somnoscreen | Somnomedics GmbH & Co. KG | 2007 | — |
| +3 | K071556 | Somnoscreen EEG10-20 | Somnomedics GmbH | 2007 | — |
| +3 | K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020 | — |
| +2 | K051907 | Innocor | Innovision A/S | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021138 | Sleepscreen/Apnoescreen Cardio | 2003 | 17 |
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?
- Of its descendants, K021138 (Erich Jaeger GmbH, 2003) has gone furthest, with 17 descendants of its own.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K000396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000396: Apnoescreen Pro, Alpha Screen Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000396
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026