510(k) · Cleared
ClearedVitascore
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitascore B.V. · MNR Ventilatory Effort Recorder
Cleared on Nov 8, 2007 as substantially equivalent to K955841 (Compumedics Ptd, Ltd., 1997) after a 108-day review. Its family tree reaches back 2 generations to 1987. 40 later devices descend from it.
- Decided
- Nov 8, 2007
- Review
- 108 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873535 (1987). 3 ancestors in all. 40 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 1 generation backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- This deviceK072014 VitascoreVitascore B.V. · 2007
- Descendant · cites it directly · 39 of its ownK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
- Descendant · 2 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · 3 generations on · 18 of its ownK120447 X4Advanced Brain Monitoring, Inc. · 2012
- Descendant · 3 generations on · 17 of its ownK130013 X4 SystemAdvanced Brain Monitoring, Inc. · 2013
- Descendant · 3 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K082968Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009 · cites it directly39descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 2 generations on38descendants
- K120447X4Advanced Brain Monitoring, Inc. · 2012 · 3 generations on18descendants
- K130013X4 SystemAdvanced Brain Monitoring, Inc. · 2013 · 3 generations on17descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −1 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| 0 (this device) | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| +1 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
| +2 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +3 | K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012 | — |
| +3 | K130013 | X4 System | Advanced Brain Monitoring, Inc. | 2013 | — |
| +3 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K955841 | Sleep System for Clinics & ResearchSummary page 1…been classified as regulatory Class I1. Predicate device Vitascore is substantially equivalent to the 'Compumedics Sleep Monitoring System', cleared under 510(k) number K955841. Vitascore is a software program to * score respiratory events * score sleep stages and arousal * indicate markers a… | 1997 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082968 | Apneicare Connection Center/Internet Analysis | 2009 | 39 |
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 20 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082968 (Apneicare, LLC, 2009) has gone furthest, with 39 descendants of its own.
- 4 other devices also cite its predicate K955841.
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 Vitascore software is a computer program, intended to be used as an aid for the diagnosis of sleep and respiratory disorders.
The Vitascore software is intended to be used for analysis (semi-automatic and manual re-scoring), display (similar to the use of a traditional paper based polygraph), redisplay (retrieve), summarize, to generate User defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders.
Vitascore is to be used under supervision of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072014 · printed Nov 3, 2026
Cite this page
510(k) Report. “K072014: Vitascore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K072014
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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