510(k) · Cleared
ClearedDevilbiss Sleep Recorder Model # RM60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical Hhg, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jul 16, 2002 as substantially equivalent to K962103 (Bio-Logic Systems Corp., 1996) and 1 other predicate after a 350-day review. Its family tree reaches back 2 generations to 1994. 42 later devices descend from it.
- Decided
- Jul 16, 2002
- Review
- 350 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930790 (1994). 4 ancestors in all. 42 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK930790 Addition of Built-in Oxymeter to Sleepscan Prod.Bio-Logic Systems Corp. · 1994
- 1 generation backK962103 Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996
- This deviceK012437 Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002
- Descendant · cites it directly · 40 of its ownK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 18 of its ownK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- Descendant · 3 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- Descendant · 4 generations on · 14 of its ownK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- Descendant · 5 generations on · 13 of its ownK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K040595ALICE 5Respironics, Inc. · 2004 · cites it directly40descendants
- K112102Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011 · 2 generations on18descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 3 generations on16descendants
- K130007Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013 · 4 generations on14descendants
- K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930790 | Addition of Built-in Oxymeter to Sleepscan Prod. | Bio-Logic Systems Corp. | 1994 | — |
| −1 | K962103 | Bio-Logic Sleepscan Product with Built-in Oximeter | Bio-Logic Systems Corp. | 1996 | — |
| 0 (this device) | K012437 | Devilbiss Sleep Recorder Model # RM60 | Sunrise Medical Hhg, Inc. | 2002 | — |
| +1 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| +2 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| +3 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| +4 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| +5 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K962103 | Bio-Logic Sleepscan Product with Built-in OximeterSummary page 1…keted Predicate Device: 510(k) Registration # Bio-Logic Sleep Scan K962103 Netlcor Puritan Bennett (Melville) Ltd. Sandman Sleep Data Storage System K934599 Description of Device: The DeVilbi… | 1996 |
| * | K934599 | SandmanSummary page 1…c Sleep Scan K962103 Netlcor Puritan Bennett (Melville) Ltd. Sandman Sleep Data Storage System K934599 Description of Device: The DeVilbiss Sleep Recorder consists of a main control box, a chest mounted interface box and several s… | 1994 |
What descends from it? (42)
See all 422 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K040595 (Respironics, Inc., 2004) has gone furthest, with 40 descendants of its own.
- 2 other devices also cite its predicate K962103.
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?
The DeVilbiss Sleep Recorder is intended for screening patients suspected of
or exhibiting symptoms of sleep disorders. The DeVilbiss Sleep Recorder
can be used with an autotitrating CPAP to record the results of CPAP
treatment for adults diagnosed with sleep apnea syndrome. Patients
suffering from excessive daytime sleepiness should be referred to a sleep
disorder specialist. The results of an unattended screening are insufficient to
identify all possible medical disorders that may produce these symptoms.
This device is intended to aid the physician in diagnosing adult sleep apnea.
A qualified medical professional should score the device’s recorded signals to
determine respiratory events.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012437: Devilbiss Sleep Recorder Model # RM60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012437
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026