510(k) · Cleared
ClearedSleep Quality
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynadx Corporation · MNR Ventilatory Effort Recorder
Cleared on Mar 20, 2008 as substantially equivalent to K042745 (Del Mar Reynolds Medical, Inc., 2005) after a 358-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Mar 20, 2008
- Review
- 358 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910870 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 4 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 3 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 2 generations backK000253 Silent Night VSleep Solutions, Inc. · 2000
- 1 generation backK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- This deviceK070855 Sleep QualityDynadx Corporation · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −4 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −3 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −2 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| −1 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| 0 (this device) | K070855 | Sleep Quality | Dynadx Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1998 | 1 | 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 |
|---|---|---|---|
| * | K042745 | Lifescreen ApneaSummary page 1…te Devices Identification: CFR21: 868.2375 Product Code: MNR Device Class: II Legally Marketed Device: Lifescreen Apnea Manufacturer: Del Mar Reynolds Medical, Inc. K#: K042745 Description: Sleep Quality is a software system, which can probe the dynamical… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 3 other devices also cite its predicate K042745.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
DynaDx Sleep Quality 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 as stated in the FDA summary.
https://510kreport.com/device/K070855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070855: Sleep Quality.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070855
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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