510(k) · Cleared
ClearedNightOwl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ectosense NV · MNR Ventilatory Effort Recorder
Cleared on Mar 6, 2020 as substantially equivalent to K161579 (Itamar Medical, Ltd., 2017) after a 323-day review. Its family tree reaches back 8 generations to 1992. 5 later devices descend from it.
- Decided
- Mar 6, 2020
- Review
- 323 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913396 (1992). 48 ancestors in all, the oldest K830295 (1983). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 7 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 6 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 5 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 4 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 3 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 2 generations backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- 1 generation backK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- This deviceK191031 NightOwlEctosense NV · 2020
- Descendant · cites it directly · 3 of its ownK213463 NightOwlEctosense NV · 2021
- Descendant · 2 generations on · 2 of its ownK220028 NightOwlEctosense NV · 2022
- Descendant · cites it directly · 0 of its ownK242224 Happy Health Home Sleep TestHappy Health, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243268 TipTraQ (TTQ001)Pranaq Pte., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK222579 Belun Sleep System BLS-100Belun Technology Company Limited · 2023
Most influential descendants
Showing 5 of 5 · See all- K213463NightOwlEctosense NV · 2021 · cites it directly3descendants
- K220028NightOwlEctosense NV · 2022 · 2 generations on2descendants
- K242224Happy Health Home Sleep TestHappy Health, Inc. · 2025 · cites it directly0descendants
- K243268TipTraQ (TTQ001)Pranaq Pte., Ltd. · 2025 · 3 generations on0descendants
- K222579Belun Sleep System BLS-100Belun Technology Company Limited · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −7 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −6 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −5 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −4 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −3 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −2 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| −1 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| 0 (this device) | K191031 | NightOwl | Ectosense NV | 2020 | — |
| +1 | K213463 | NightOwl | Ectosense NV | 2021 | — |
| +2 | K220028 | NightOwl | Ectosense NV | 2022 | — |
| +1 | K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | 2025 | — |
| +3 | K243268 | TipTraQ (TTQ001) | Pranaq Pte., Ltd. | 2025 | — |
| +3 | K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K161579 | Watch-PAT200USummary page 5…Class II, Ventilatory Effort Recorder, Product Code: MNR; 21 CFR 068.2375 3. PREDICATE DEVICE Predicate: Itamar Medical Ltd’s WatchPAT 200U (K161579) 4. DEVICE DESCRIPTION The NightOwl is prescribed by a Health Care Professional for the patient to use in the home as a ‘home… | 2017 |
What descends from it? (5)
2 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 28 years and passes through 9 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 48 ancestors have a recall of any class.
- Of its descendants, K213463 (Ectosense NV, 2021) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K161579.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea.
The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191031: NightOwl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191031
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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