510(k) · Cleared
ClearedSleepstrip II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.L.P., Ltd. · MNR Ventilatory Effort Recorder
Cleared on Dec 27, 2011 as substantially equivalent to K002135 (Influent, Ltd., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Dec 27, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002135 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002135 Sleepstrip Disposable Apnea ScreenerInfluent, Ltd. · 2000
- This deviceK112822 Sleepstrip IIS.L.P., Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK173974 DrowzleResonea, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK210480 AcuPebble SAAcurable Limited · 2021
- Descendant · 3 generations on · 1 of its ownK222950 AcuPebble OX100Acurable Limited · 2023
- Descendant · 4 generations on · 0 of its ownK243092 AcuPebble Ox (200)Acurable Limited · 2025
- Descendant · 2 generations on · 0 of its ownK231667 Withings Sleep RxWithings · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173974DrowzleResonea, Inc. · 2019 · cites it directly5descendants
- K210480AcuPebble SAAcurable Limited · 2021 · 2 generations on2descendants
- K222950AcuPebble OX100Acurable Limited · 2023 · 3 generations on1descendant
- K243092AcuPebble Ox (200)Acurable Limited · 2025 · 4 generations on0descendants
- K231667Withings Sleep RxWithings · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002135 | Sleepstrip Disposable Apnea Screener | Influent, Ltd. | 2000 | — |
| 0 (this device) | K112822 | Sleepstrip II | S.L.P., Ltd. | 2011 | — |
| +1 | K173974 | Drowzle | Resonea, Inc. | 2019 | — |
| +2 | K210480 | AcuPebble SA | Acurable Limited | 2021 | — |
| +3 | K222950 | AcuPebble OX100 | Acurable Limited | 2023 | — |
| +4 | K243092 | AcuPebble Ox (200) | Acurable Limited | 2025 | — |
| +2 | K231667 | Withings Sleep Rx | Withings | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002135 | Sleepstrip Disposable Apnea ScreenerSummary page 1…de MINR; Regulation No. 868.2375 Panel: Anesthesiology 7.1.7 Predicate Device: SleepStip cleared under K002135. 7.1.8 Device Description: The SleepStrip 11 is formed like a soft plastic 'strip' or patch which is adhesively applied o… | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173974 | Drowzle | 2019 | 5 |
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?
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The SleepStrip I1 is intended to measure apnealhyponea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112822: Sleepstrip II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112822
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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