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 Dec 16, 2021 as substantially equivalent to K191031 (Ectosense NV, 2020) after a 50-day review. Its family tree reaches back 9 generations to 1992. 3 later devices descend from it.
- Decided
- Dec 16, 2021
- Review
- 50 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913396 (1992). 49 ancestors in all, the oldest K830295 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 5 generations between
- 3 generations backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- 2 generations backK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- 1 generation backK191031 NightOwlEctosense NV · 2020
- This deviceK213463 NightOwlEctosense NV · 2021
- Descendant · cites it directly · 2 of its ownK220028 NightOwlEctosense NV · 2022
- Descendant · 2 generations on · 0 of its ownK243268 TipTraQ (TTQ001)Pranaq Pte., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK222579 Belun Sleep System BLS-100Belun Technology Company Limited · 2023
Show all 9 generations
- Root · 9 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 8 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 7 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 6 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 5 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 4 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 3 generations backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- 2 generations backK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- 1 generation backK191031 NightOwlEctosense NV · 2020
- This deviceK213463 NightOwlEctosense NV · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −8 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −7 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −6 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −5 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −4 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −3 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| −2 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| −1 | K191031 | NightOwl | Ectosense NV | 2020 | — |
| 0 (this device) | K213463 | NightOwl | Ectosense NV | 2021 | — |
| +1 | K220028 | NightOwl | Ectosense NV | 2022 | — |
| +2 | K243268 | TipTraQ (TTQ001) | Pranaq Pte., Ltd. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K191031 | NightOwlSummary page 5…t Code/CFR Reference Class II, Ventilatory Effort Recorder, Product Code: MNR; 21 CFR 068.2375 3. PREDICATE DEVICE Predicate: Ectosense’s NightOwl (K191031) 4. DEVICE DESCRIPTION The NightOwl is prescribed by a Health Care Professional for the patient to use in the home as a ‘… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220028 | NightOwl | 2022 | 2 |
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 29 years and passes through 9 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 49 ancestors have a recall of any class.
- Of its descendants, K220028 (Ectosense NV, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K191031.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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/K213463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213463: NightOwl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213463
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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