510(k) · Cleared
ClearedAlice PDX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · MNR Ventilatory Effort Recorder
Cleared on Jun 26, 2009 after a 121-day review. The FDA summary names its predicate without a number. 79 later devices descend from it.
- Decided
- Jun 26, 2009
- Review
- 121 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 4 citing it directly.
- This deviceK090484 Alice PDXRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · cites it directly · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 2 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · cites it directly · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · 2 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- Descendant · 3 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · cites it directly40descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 2 generations on38descendants
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · cites it directly35descendants
- K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 2 generations on24descendants
- K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090484 | Alice PDX | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +1 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +2 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +1 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +2 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| +3 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | — | Respironics Galaxy Named without a submission number |
What descends from it? (79)
See all 794 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, K111194 (Advanced Brain Monitoring, Inc., 2011) has gone furthest, with 40 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. 2009, 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 Alice PDx is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090484 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090484: Alice PDX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090484
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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