510(k) · Cleared
ClearedSleepstrip Disposable Apnea Screener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influent, Ltd. · MNR Ventilatory Effort Recorder
Cleared on Dec 6, 2000 after a 145-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Dec 6, 2000
- Review
- 145 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK002135 Sleepstrip Disposable Apnea ScreenerInfluent, Ltd. · 2000
- Descendant · cites it directly · 6 of its ownK112822 Sleepstrip IIS.L.P., Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK173974 DrowzleResonea, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK030869 BitestripS.L.P., Ltd. · 2004
- Descendant · 3 generations on · 2 of its ownK210480 AcuPebble SAAcurable Limited · 2021
- Descendant · 2 generations on · 2 of its ownK092675 GrindcareMedotech A/S · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112822Sleepstrip IIS.L.P., Ltd. · 2011 · cites it directly6descendants
- K173974DrowzleResonea, Inc. · 2019 · 2 generations on5descendants
- K030869BitestripS.L.P., Ltd. · 2004 · cites it directly3descendants
- K210480AcuPebble SAAcurable Limited · 2021 · 3 generations on2descendants
- K092675GrindcareMedotech A/S · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002135 | Sleepstrip Disposable Apnea Screener | Influent, Ltd. | 2000 | — |
| +1 | K112822 | Sleepstrip II | S.L.P., Ltd. | 2011 | — |
| +2 | K173974 | Drowzle | Resonea, Inc. | 2019 | — |
| +1 | K030869 | Bitestrip | S.L.P., Ltd. | 2004 | — |
| +3 | K210480 | AcuPebble SA | Acurable Limited | 2021 | — |
| +2 | K092675 | Grindcare | Medotech A/S | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 133 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?
- Of its descendants, K112822 (S.L.P., Ltd., 2011) has gone furthest, with 6 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.
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 | — |
https://510kreport.com/device/K002135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002135: Sleepstrip Disposable Apnea Screener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002135
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026