510(k) · Cleared
ClearedSleepsense Sleep Sensors
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 Oct 6, 2004 as substantially equivalent to K941759 (Epm Development Systems Corp., 1994) and 2 other predicates after a 47-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- Oct 6, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K903300 (1990). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK903300 Resp-EZ (TM) Respiratory Monitoring BeltEpm Information Systems, Inc. · 1990
- This deviceK042253 Sleepsense Sleep SensorsS.L.P., Ltd. · 2004
- Descendant · cites it directly · 1 of its ownK173793 XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019
- Descendant · 2 generations on · 0 of its ownK242424 Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK180001 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult /…Embla Systems · 2019
- Descendant · cites it directly · 0 of its ownK080375 RMX Physiological Data RecorderS.L.P., Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems · 2019 · cites it directly1descendant
- K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc. · 2024 · 2 generations on0descendants
- K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable…Embla Systems · 2019 · cites it directly0descendants
- K080375RMX Physiological Data RecorderS.L.P., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903300 | Resp-EZ (TM) Respiratory Monitoring Belt | Epm Information Systems, Inc. | 1990 | — |
| 0 (this device) | K042253 | Sleepsense Sleep Sensors | S.L.P., Ltd. | 2004 | — |
| +1 | K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019 | — |
| +2 | K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | 2024 | — |
| +1 | K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child… | Embla Systems | 2019 | — |
| +1 | K080375 | RMX Physiological Data Recorder | S.L.P., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941759 | Snoring SensorSummary page 2…kind. Predicate Device: Device Applicant 510(k) Decision Date snoring sensor EPM development systems I K941759 II 11/10/1994 moving images(tm) EPM information systems 05/17/1994 the tracker… | 1994 |
| Kept off the family tree | K930303 | FDA’s K930303 is Datascope Multinex ID Plus Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1993 |
| * | K922112 | EasyflowSummary page 2…EPM information systemsf_1923033 1 06/01/1993 easyflow ft]EPM information systems [K922112 12/07/1992 resp-ez(tm) respirat K903300 12/28/1990 Performance Stand… | 1992 |
| * | K903300 | Resp-EZ (TM) Respiratory Monitoring BeltSummary page 2…ft]EPM information systems [K922112 12/07/1992 resp-ez(tm) respirat K903300 12/28/1990 Performance Standards: No performance standards are specified for physiological sensors for sleep disorde… | 1990 |
| * | — | moving images (tm) Named without a submission number |
What descends from it? (4)
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?
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 | — |
What is it indicated for?
SleepSense sleep sensors provide a qualitative measure of some physiological parameters for recording onto an FDA-cleared data acquisition system. Their target population: Children and adult patients who are screened during sleep disorder studies. Their environment of use is usually at a sleep laboratory or sometimes at the patient's home.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042253 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042253: Sleepsense Sleep Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042253
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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