510(k) · Cleared
ClearedOnera STS 2 (ONERA STS 2)
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 Jul 3, 2025 as substantially equivalent to K223573 (Onera B.V., 2023) after a 269-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jul 3, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913396 (1992). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 5 generations between
- 3 generations backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- 2 generations backK210593 Onera Sleep Test System (Onera STS)Onera B.V. · 2022
- 1 generation backK223573 Onera Sleep Test System (Onera STS)Onera B.V. · 2023
- This deviceK243220 Onera STS 2 (ONERA STS 2)Onera B.V. · 2025
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 backK210593 Onera Sleep Test System (Onera STS)Onera B.V. · 2022
- 1 generation backK223573 Onera Sleep Test System (Onera STS)Onera B.V. · 2023
- This deviceK243220 Onera STS 2 (ONERA STS 2)Onera B.V. · 2025
View 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 | K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2022 | — |
| −1 | K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K223573 | Onera Sleep Test System (Onera STS)Summary page 6…e same indications as the predicate device. Legally marketed Predicate Device: 510(k) Number Device Name Type K223573 Onera STS Predicate device Technological Comparison: The table below provides… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 8 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 30 ancestors have a recall of any class.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders.
Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography 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 the healthcare professional to assist in the diagnosis of sleep disorders.
The device is intended to be used for adults.
The device is not a life supporting physiological monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243220: Onera STS 2 (ONERA STS 2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243220
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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