510(k) · Cleared
ClearedDrowzle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resonea, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jul 14, 2019 as substantially equivalent to K112822 (S.L.P., Ltd., 2011) after a 562-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- Jul 14, 2019
- Review
- 562 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002135 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002135 Sleepstrip Disposable Apnea ScreenerInfluent, Ltd. · 2000
- 1 generation backK112822 Sleepstrip IIS.L.P., Ltd. · 2011
- This deviceK173974 DrowzleResonea, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK210480 AcuPebble SAAcurable Limited · 2021
- Descendant · 2 generations on · 1 of its ownK222950 AcuPebble OX100Acurable Limited · 2023
- Descendant · 3 generations on · 0 of its ownK243092 AcuPebble Ox (200)Acurable Limited · 2025
- Descendant · cites it directly · 0 of its ownK231667 Withings Sleep RxWithings · 2024
- Descendant · cites it directly · 0 of its ownK213360 SleepCheckRxResapp Health · 2022
Most influential descendants
Showing 5 of 5 · See all- K210480AcuPebble SAAcurable Limited · 2021 · cites it directly2descendants
- K222950AcuPebble OX100Acurable Limited · 2023 · 2 generations on1descendant
- K243092AcuPebble Ox (200)Acurable Limited · 2025 · 3 generations on0descendants
- K231667Withings Sleep RxWithings · 2024 · cites it directly0descendants
- K213360SleepCheckRxResapp Health · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002135 | Sleepstrip Disposable Apnea Screener | Influent, Ltd. | 2000 | — |
| −1 | K112822 | Sleepstrip II | S.L.P., Ltd. | 2011 | — |
| 0 (this device) | K173974 | Drowzle | Resonea, Inc. | 2019 | — |
| +1 | K210480 | AcuPebble SA | Acurable Limited | 2021 | — |
| +2 | K222950 | AcuPebble OX100 | Acurable Limited | 2023 | — |
| +3 | K243092 | AcuPebble Ox (200) | Acurable Limited | 2025 | — |
| +1 | K231667 | Withings Sleep Rx | Withings | 2024 | — |
| +1 | K213360 | SleepCheckRx | Resapp Health | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
What descends from it? (5)
3 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 19 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210480 (Acurable Limited, 2021) has gone furthest, with 2 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. 2019, 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?
DROWZLE is indicated to record a patient’s respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation.
The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173974: Drowzle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173974
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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