# K040595: ALICE 5

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Mar 18, 2004 after 10 days
- Product code: OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962603 (1997). 9 ancestors in all.
40 later devices descend from it; 7 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971867: Alice 4R System, Healthdyne Technologies, Inc. (1997) Summary page 1.
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis, Masimo Corp. (1999) Summary page 1.
- K012437: Devilbiss Sleep Recorder Model # RM60, Sunrise Medical Hhg, Inc. (2002) Summary page 3.

## Most influential descendants
- K112102: Michele Sleep Scoring Systems (2011), 18 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own
- K130007: Sleep Profiler (2013), 14 descendants of its own
- K153412: Sleep Profiler (2016), 13 descendants of its own
- K162627: EnsoSleep (2017), 9 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1057-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The Alice 5 System is a Polysomnography System that is intended to record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders. This device does not provide alarms and, is not intended for use as an automated apnea monitor.

Source page: https://510kreport.com/device/K040595
Methodology: https://510kreport.com/methodology