510(k) · Cleared
ClearedAcuPebble Ox (200)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acurable Limited · MNR Ventilatory Effort Recorder
Cleared on Mar 19, 2025 as substantially equivalent to K222950 (Acurable Limited, 2023) after a 170-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 19, 2025
- Review
- 170 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002135 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK002135 Sleepstrip Disposable Apnea ScreenerInfluent, Ltd. · 2000
- 4 generations backK112822 Sleepstrip IIS.L.P., Ltd. · 2011
- 3 generations backK173974 DrowzleResonea, Inc. · 2019
- 2 generations backK210480 AcuPebble SAAcurable Limited · 2021
- 1 generation backK222950 AcuPebble OX100Acurable Limited · 2023
- This deviceK243092 AcuPebble Ox (200)Acurable Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002135 | Sleepstrip Disposable Apnea Screener | Influent, Ltd. | 2000 | — |
| −4 | K112822 | Sleepstrip II | S.L.P., Ltd. | 2011 | — |
| −3 | K173974 | Drowzle | Resonea, Inc. | 2019 | — |
| −2 | K210480 | AcuPebble SA | Acurable Limited | 2021 | — |
| −1 | K222950 | AcuPebble OX100 | Acurable Limited | 2023 | — |
| 0 (this device) | K243092 | AcuPebble Ox (200) | Acurable Limited | 2025 | — |
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 |
|---|---|---|---|
| * | K222950 | AcuPebble OX100Summary page 6…ebble Ox200 comprises: 1- A small microphones/accelerometer sensor, identical to the one in the previously cleared devices AcuPebble SA100 (K210480) and AcuPebble Ox100 (K222950) that is worn on the front of the neck around the suprasternal notch area (the “AcuPebble SA100 sensor”), and attaches with a sin… | 2023 |
| † | K242798 | Airmod | 2025 |
| † | K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | 2024 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
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?
AcuPebble Ox200 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA).The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243092 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243092: AcuPebble Ox (200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243092
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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