510(k) · Cleared
ClearedAlice 4R System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthdyne Technologies, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Aug 13, 1997 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 105 later devices descend from it.
- Decided
- Aug 13, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 0
105 later devices descend from it, 4 citing it directly.
- This deviceK971867 Alice 4R SystemHealthdyne Technologies, Inc. · 1997
- Descendant · cites it directly · 61 of its ownK971813 EMBLAFerguson Medical · 1998
- Descendant · cites it directly · 40 of its ownK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 25 of its ownK080427 Watch-Pat Model 100S-2Itamar Medical · 2008
- Descendant · 3 generations on · 24 of its ownK081982 Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008
- Descendant · 2 generations on · 23 of its ownK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K971813EMBLAFerguson Medical · 1998 · cites it directly61descendants
- K040595ALICE 5Respironics, Inc. · 2004 · cites it directly40descendants
- K080427Watch-Pat Model 100S-2Itamar Medical · 2008 · 2 generations on25descendants
- K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008 · 3 generations on24descendants
- K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971867 | Alice 4R System | Healthdyne Technologies, Inc. | 1997 | — |
| +1 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| +1 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| +2 | K080427 | Watch-Pat Model 100S-2 | Itamar Medical | 2008 | — |
| +3 | K081982 | Watch-Pat 200S-2 (WP200S-2) | Itamar Medical | 2008 | — |
| +2 | K102567 | Watch-Pat 200S-3 (WP200S-3) | Itamar Medical, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 13 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (105)
See all 1054 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, K971813 (Ferguson Medical, 1998) has gone furthest, with 61 descendants of its own.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
- The Alice® 4 Sysfem is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971867: Alice 4R System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971867
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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