510(k) · Cleared
ClearedOnera Sleep Test System (Onera STS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onera B.V. · MNR Ventilatory Effort Recorder
Cleared on Apr 6, 2022 as substantially equivalent to K122516 (Embla Systems, 2013) after a 401-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Apr 6, 2022
- Review
- 401 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913396 (1992). 28 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 5 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 4 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 3 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 2 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 1 generation backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- This deviceK210593 Onera Sleep Test System (Onera STS)Onera B.V. · 2022
- Descendant · cites it directly · 1 of its ownK223573 Onera Sleep Test System (Onera STS)Onera B.V. · 2023
- Descendant · cites it directly · 0 of its ownK260050 WRAP SystemHuneo, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK243220 Onera STS 2 (ONERA STS 2)Onera B.V. · 2025
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 |
|---|---|---|---|---|---|
| −7 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −6 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −5 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −4 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −3 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −1 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| 0 (this device) | K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2022 | — |
| +1 | K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2023 | — |
| +1 | K260050 | WRAP System | Huneo, LLC | 2026 | — |
| +2 | K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K122516 | Embletta MPRSummary page 5…d to be used for adults. Legally marketed devices to which substantial equivalence is claimed 510(k) Number Device Name Type k122516 Embletta MPR Predicate device k161531 MP50 IntelliVue Patient Monitor… | 2013 |
| † | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2… | 2016 |
What descends from it? (3)
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 8 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K223573 (Onera B.V., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122516.
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?
Onera STS measures and records multiple physiological parameters from a patient during a sleep study which are used by
clinicians to make a decision on the diagnosis of sleep disorders.
Onera STS is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The
device is designed to be used under the direction of a physician or trained technician but applied by a layperson.
The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.
The device is intended to be used for adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210593: Onera Sleep Test System (Onera STS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210593
Report an extraction error
Are you the manufacturer?
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