510(k) · Cleared
Recalled · 2011Lifescreen Apnea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Del Mar Reynolds Medical, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jan 19, 2005 as substantially equivalent to K000253 (Sleep Solutions, Inc., 2000) after a 107-day review. Its family tree reaches back 4 generations to 1991. 63 later devices descend from it. It has been recalled once.
- Decided
- Jan 19, 2005
- Review
- 107 days
- Class
- Class II
- Product code
- MNR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910870 (1991). 8 ancestors in all. 63 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 3 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 2 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 1 generation backK000253 Silent Night VSleep Solutions, Inc. · 2000
- This deviceK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005
- Descendant · cites it directly · 53 of its ownK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
- Descendant · 2 generations on · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
- Descendant · 2 generations on · 45 of its ownK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
- Descendant · 3 generations on · 40 of its ownK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
- Descendant · 3 generations on · 29 of its ownK141518 Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K083325N-600X with SPD, Oximax N-600XCovidien · 2009 · cites it directly53descendants
- K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · 2 generations on49descendants
- K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien · 2012 · 2 generations on45descendants
- K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien · 2014 · 3 generations on40descendants
- K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −3 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −2 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −1 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| 0 (this device) | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | — |
| +1 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | — |
| +2 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
| +2 | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient… | Covidien | 2012 | — |
| +3 | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient… | Covidien | 2014 | — |
| +3 | K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Covidien | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 10 | 0 |
| 2023 | 1 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K000253 | Silent Night VSummary page 4…on Name: Apnea Examination System Classification name: Ventilatory Effort Recorder 3. Equivalent legally-marketed devices. Silent Night V, K000253, manufactured by Sleep Solutions 4. Description Lifescreen Apnea is a software option for the LifeScreen ECU Hotter scanni… | 2000 |
What descends from it? (63)
See all 634 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2011 | Not classified | Z-0520-2012 | Software design | When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have to be longer than 32… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K083325 (Covidien, 2009) has gone furthest, with 53 descendants of its own.
- 2 other devices also cite its predicate K000253.
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 device is intended for use on adult patients only as a screening device to determine
the need for clinical diagnosis and evaluation by polysomnography based on the patient’s
score. The ECG recording may be obtained at any location specified by a physician
including home, hospital or clinic. Subjects screened for sleep apnea should have periods
of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm
in nature.
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/K042745 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042745: Lifescreen Apnea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042745
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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