510(k) · Cleared
ClearedAcuPebble OX100
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 Feb 3, 2023 as substantially equivalent to K210480 (Acurable Limited, 2021) after a 129-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Feb 3, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002135 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002135 Sleepstrip Disposable Apnea ScreenerInfluent, Ltd. · 2000
- 3 generations backK112822 Sleepstrip IIS.L.P., Ltd. · 2011
- 2 generations backK173974 DrowzleResonea, Inc. · 2019
- 1 generation backK210480 AcuPebble SAAcurable Limited · 2021
- This deviceK222950 AcuPebble OX100Acurable Limited · 2023
- Descendant · cites it directly · 0 of its ownK243092 AcuPebble Ox (200)Acurable Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K243092AcuPebble Ox (200)Acurable Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002135 | Sleepstrip Disposable Apnea Screener | Influent, Ltd. | 2000 | — |
| −3 | K112822 | Sleepstrip II | S.L.P., Ltd. | 2011 | — |
| −2 | K173974 | Drowzle | Resonea, Inc. | 2019 | — |
| −1 | K210480 | AcuPebble SA | Acurable Limited | 2021 | — |
| 0 (this device) | K222950 | AcuPebble OX100 | Acurable Limited | 2023 | — |
| +1 | K243092 | AcuPebble Ox (200) | Acurable Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K210480 | AcuPebble SASummary page 5…home as a ‘home sleep apnea test’ (HSAT). AcuPebble Ox100 comprises: 1‐ A small physiological sensing device, identical to the previously cleared device AcuPebble SA100 (K210480) that is worn on the front of the neck around the suprasternal notch area (the “AcuPebble SA100 sensor”), and attaches with a sin… | 2021 |
| † | K191031 | NightOwl | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243092 | AcuPebble Ox (200) | 2025 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K243092 (Acurable Limited, 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. 2023, 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 Ox100 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/K222950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222950: AcuPebble OX100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222950
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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