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 Feb 24, 2022 as substantially equivalent to K213463 (Ectosense NV, 2021) after a 50-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 24, 2022
- Review
- 50 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913396 (1992). 50 ancestors in all, the oldest K830295 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations between
- 3 generations backK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- 2 generations backK191031 NightOwlEctosense NV · 2020
- 1 generation backK213463 NightOwlEctosense NV · 2021
- This deviceK220028 NightOwlEctosense NV · 2022
- Descendant · cites it directly · 0 of its ownK243268 TipTraQ (TTQ001)Pranaq Pte., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK222579 Belun Sleep System BLS-100Belun Technology Company Limited · 2023
Show all 10 generations
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 9 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 8 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 7 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 6 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 5 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 4 generations backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- 3 generations backK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- 2 generations backK191031 NightOwlEctosense NV · 2020
- 1 generation backK213463 NightOwlEctosense NV · 2021
- This deviceK220028 NightOwlEctosense NV · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −9 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −8 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −7 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −6 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −5 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −4 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| −3 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| −2 | K191031 | NightOwl | Ectosense NV | 2020 | — |
| −1 | K213463 | NightOwl | Ectosense NV | 2021 | — |
| 0 (this device) | K220028 | NightOwl | Ectosense NV | 2022 | — |
| +1 | K243268 | TipTraQ (TTQ001) | Pranaq Pte., Ltd. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K213463 | NightOwlSummary page 5…tory Effort Recorder, Product Code: MNR; 21 CFR 868.2375 \\\DC - 073662/000600 - 2618843 v1 3. PREDICATE DEVICE Predicate: Ectosense’s NightOwl (K213463) 4. DEVICE DESCRIPTION The NightOwl is prescribed by a Health Care Professional for the patient to use in the home as a ‘… | 2021 |
What descends from it? (2)
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 30 years and passes through 9 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 50 ancestors have a recall of any class.
- Of its descendants, K243268 (Pranaq Pte., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220028: NightOwl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220028
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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