510(k) · Cleared
ClearedMorpheus OX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Widemed, Ltd. · MNR Ventilatory Effort Recorder
Cleared on Aug 31, 2011 as substantially equivalent to K070326 (Widemed, Ltd., 2007) and 3 other predicates after a 113-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Aug 31, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K913396 (1992). 44 ancestors in all, the oldest K873535 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 5 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 4 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 3 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 2 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 1 generation backK070263 ApnealinkResmed Germany, Inc. · 2007
- This deviceK111314 Morpheus OXWidemed, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −6 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −5 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −4 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −3 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −2 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −1 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| 0 (this device) | K111314 | Morpheus OX | Widemed, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2007 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K070326 | Noga Automated Sleep Study Scoring and Data Management SystemSummary page 1…anel: Anesthesiology 5.11 Predicate Devices: I. The Noga Automated Sleep Study Scoring and Data Management System (WideMed, Ltd.), cleared under K070326 2. Apnealink (Resmed, Germany) cleared under K070263 3. ARES (Advanced Brain Monitoring, Inc, USA) cleared unde… | 2007 |
| * | K070263 | ApnealinkSummary page 1…e Noga Automated Sleep Study Scoring and Data Management System (WideMed, Ltd.), cleared under K070326 2. Apnealink (Resmed, Germany) cleared under K070263 3. ARES (Advanced Brain Monitoring, Inc, USA) cleared under K07 1230 4. Somnomedics SOMNOscreen (Somnomedics GM… | 2007 |
| * | K071230 | Apnea Risk Evaluation System (Ares), Model 600Summary page 1…(WideMed, Ltd.), cleared under K070326 2. Apnealink (Resmed, Germany) cleared under K070263 3. ARES (Advanced Brain Monitoring, Inc, USA) cleared under K07 1230 4. Somnomedics SOMNOscreen (Somnomedics GMBH & Company KG.); cleared under K060708… | 2007 |
| * | K060708 | SomnoscreenSummary page 1…3. ARES (Advanced Brain Monitoring, Inc, USA) cleared under K07 1230 4. Somnomedics SOMNOscreen (Somnomedics GMBH & Company KG.); cleared under K060708 5-3 5.12 Performance Standards: 1. IEC 60601-1-4 + Al, Med… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 44 ancestors has a recall of any class.
- 1 other device also cites its predicate K070326.
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 Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of…
Read the full statement (149 words)
The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of physiological data received from an oximeter device. It does not perform automatic classification of respiratory events as central or obstructive. This system is to be used under the supervision of a physician.
Morpheus Ox displays heart rate, saturation and photoplethysmograph signals, acquired from an oximeter device. Morpheus Ox may also display signals including: EtCO2, Respiratory impedance, Plethysmograph Derived Respiratory (PDR) calculated signal, Activity, ECG, EEG, P flow, T flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111314: Morpheus OX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111314
Report an extraction error
Are you the manufacturer?
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