# K090484: Alice PDX

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Jun 26, 2009 after 121 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
79 later devices descend from it; 4 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Respironics Galaxy: named in the summary without a submission number

## Most influential descendants
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own
- K112514: Apnea Risk Evaluation System (Ares) (2012), 38 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K090484
Methodology: https://510kreport.com/methodology