510(k) · Cleared
ClearedSleepscreen/Apnoescreen Cardio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erich Jaeger GmbH · MNR Ventilatory Effort Recorder
Cleared on Feb 12, 2003 as substantially equivalent to K000396 (Erich Jaeger, Inc., 2000) after a 309-day review. Its family tree reaches back 1 generation to 2000. 17 later devices descend from it.
- Decided
- Feb 12, 2003
- Review
- 309 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000396 (2000). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000396 Apnoescreen Pro, Alpha Screen ProErich Jaeger, Inc. · 2000
- This deviceK021138 Sleepscreen/Apnoescreen CardioErich Jaeger GmbH · 2003
- Descendant · cites it directly · 11 of its ownK060708 SomnoscreenSomnomedics GmbH & Co. KG · 2007
- Descendant · 2 generations on · 5 of its ownK071556 Somnoscreen EEG10-20Somnomedics GmbH · 2007
- Descendant · 2 generations on · 4 of its ownK201054 SOMNOscreen plusSomnomedics GmbH · 2020
- Descendant · cites it directly · 4 of its ownK051907 InnocorInnovision A/S · 2006
- Descendant · 2 generations on · 3 of its ownK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K060708SomnoscreenSomnomedics GmbH & Co. KG · 2007 · cites it directly11descendants
- K071556Somnoscreen EEG10-20Somnomedics GmbH · 2007 · 2 generations on5descendants
- K201054SOMNOscreen plusSomnomedics GmbH · 2020 · 2 generations on4descendants
- K051907InnocorInnovision A/S · 2006 · cites it directly4descendants
- K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000396 | Apnoescreen Pro, Alpha Screen Pro | Erich Jaeger, Inc. | 2000 | — |
| 0 (this device) | K021138 | Sleepscreen/Apnoescreen Cardio | Erich Jaeger GmbH | 2003 | — |
| +1 | K060708 | Somnoscreen | Somnomedics GmbH & Co. KG | 2007 | — |
| +2 | K071556 | Somnoscreen EEG10-20 | Somnomedics GmbH | 2007 | — |
| +2 | K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020 | — |
| +1 | K051907 | Innocor | Innovision A/S | 2006 | — |
| +2 | K071911 | Cardiopulmonary Exercise Testing Option to Innocor | Innovision A/S | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K000396 | Apnoescreen Pro, Alpha Screen ProSummary page 1…ApnoeScreer! Cardio is an Erich Jaeger GmbH device classified under 73MBZ, “Ventilatory Effort Recorder, per Regulation No. 868.2375. Predicate Device: ApnoeScreen Pro (K000396) Intended Use: The Sleepscreen and ApnoeScreen Cardio are portable physiological signal recording devices intended to be used f… | 2000 |
What descends from it? (17)
See all 172 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?
- Its one ancestor has no recall.
- Of its descendants, K060708 (Somnomedics GmbH & Co. KG, 2007) has gone furthest, with 11 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 | — |
What is it indicated for?
The Sleepscreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The Sleepscreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the…
Read the full statement (144 words)
The Sleepscreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The Sleepscreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital.
The Sleepscreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the Sleepscreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021138 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021138: Sleepscreen/Apnoescreen Cardio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021138
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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