510(k) · Cleared
ClearedMichele Sleep Scoring Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Younes Sleep Technologies · MNR Ventilatory Effort Recorder
Cleared on Dec 20, 2011 as substantially equivalent to K040595 (Respironics, Inc., 2004) and 2 other predicates after a 151-day review. Its family tree reaches back 4 generations to 1997. 18 later devices descend from it.
- Decided
- Dec 20, 2011
- Review
- 151 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K962603 (1997). 15 ancestors in all, the oldest K873535 (1987). 18 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- This deviceK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- Descendant · cites it directly · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- Descendant · 2 generations on · 14 of its ownK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- Descendant · 3 generations on · 13 of its ownK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- Descendant · 4 generations on · 9 of its ownK162627 EnsoSleepEnsodata, Inc. · 2017
- Descendant · 5 generations on · 3 of its ownK221179 SomnoMetryNeumetry Medical, Inc. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · cites it directly16descendants
- K130007Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013 · 2 generations on14descendants
- K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016 · 3 generations on13descendants
- K162627EnsoSleepEnsodata, Inc. · 2017 · 4 generations on9descendants
- K221179SomnoMetryNeumetry Medical, Inc. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| 0 (this device) | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| +1 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| +2 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| +3 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| +4 | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
| +5 | K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K040595 | ALICE 5Summary page 1…o which Substantial Equivalence is Claimed: 1. Trade Name: Alice 5 System Respironics Inc. 5 10(k) Number: K040595 Classification Name: ElectroencephalographylPolysomnography System Class: 11 Product… | 2004 |
| * | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management SystemSummary page 2…s TM1, Automated Sleep Study Scoring and Data Management System WideMed Ltd. 5 10O(k) Number: K022506 Classification Name: Ventilatory Effort Recorder Class: I Product Code: MNR… | 2003 |
| * | K083620 | Somnolyzer 24X7Summary page 2…Breathing Frequency Monitor 3. Trade Name: Somnolyzer® 24x7 The Siesta Group North America 510O(k) Number: K083620 Classification Name: Ventilatory Effort Recorder Class: 11 Product Code: MNR… | 2009 |
What descends from it? (18)
See all 183 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K120450 (Advanced Brain Monitoring, Inc., 2012) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K040595.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders.
The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarizing, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112102: Michele Sleep Scoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112102
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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