510(k) · Cleared
Recalled · 2007ALICE 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Mar 18, 2004 as substantially equivalent to K971867 (Healthdyne Technologies, Inc., 1997) and 2 other predicates after a 10-day review. Its family tree reaches back 3 generations to 1997. 40 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K962603 (1997). 9 ancestors in all, the oldest K930790 (1994). 40 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 2 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 1 generation backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- This deviceK040595 ALICE 5Respironics, Inc. · 2004
- Descendant · cites it directly · 18 of its ownK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- Descendant · 2 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- Descendant · 3 generations on · 14 of its ownK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- Descendant · 4 generations on · 13 of its ownK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- Descendant · 5 generations on · 9 of its ownK162627 EnsoSleepEnsodata, Inc. · 2017
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K112102Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011 · cites it directly18descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 2 generations on16descendants
- K130007Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013 · 3 generations on14descendants
- K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016 · 4 generations on13descendants
- K162627EnsoSleepEnsodata, Inc. · 2017 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −2 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −1 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| 0 (this device) | K040595 | ALICE 5 | Respironics, Inc. | 2004 | — |
| +1 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| +2 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| +3 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| +4 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| +5 | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 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 OLZ? 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 OLZ device
- #1 K253390 Somnum (Somnum)score 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K971867 | Alice 4R SystemSummary page 1…ification Reference 21 CFR 882.1400 Classification Class Il Appropriate Classification Panel Neurology Product Code OLZ, OLl/ Predicate Devices Respironics Alice 4R (K971867) Masimo SET Oximeter (K990966) Devilbiss Sleep Recorder (KO12437) Reason for submission Modified design Substantial Equivalenc… | 1997 |
| * | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Summary page 1…1400 Classification Class Il Appropriate Classification Panel Neurology Product Code OLZ, OLl/ Predicate Devices Respironics Alice 4R (K971867) Masimo SET Oximeter (K990966) Devilbiss Sleep Recorder (KO12437) Reason for submission Modified design Substantial Equivalence This premarket notilication… | 1999 |
| * | K012437 | Devilbiss Sleep Recorder Model # RM60Summary page 3…s Inc. 3/3/2004 T page Abbreviated 510{k) Tab 10 - 510{K) Summary Alice 5 Characteristic Alice 4R (K97xx) Devilbiss Sleep Recorder, Alice 5 Model RM60 (K012437) The Alice 4 Systemis a The Devilbiss Sleep Recorder | The Alice & Systemiis a Intended Use polysemnography system that | is int… | 2002 |
What descends from it? (40)
See all 407 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112102 | Michele Sleep Scoring Systems | 2011 | 18 |
| K061996 | Sandman Pocket | 2006 | 7 |
| K201054 | SOMNOscreen plus | 2020 | 4 |
| K142988 | Sleepware G3 | 2015 | 4 |
| K070326 | Noga Automated Sleep Study Scoring and Data Management System | 2007 | 2 |
| K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software | 2015 | 1 |
| K111055 | Galaxy System; Jupiter | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1057-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K112102 (Younes Sleep Technologies, 2011) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K971867.
How does its category compare?
All OLZ devicesOLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLZ
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLZ
No recall names OLZ since 2007.
Adverse event reports per year · OLZ
3in 2025
MAUDE reports naming product code OLZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 122 | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 4 | 185 | 0 | 3 |
| 2026 | 3 | 155 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040595: ALICE 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040595
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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