510(k) · Cleared
ClearedCompumedics Siesta System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Limited · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Dec 27, 2000 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 77 later devices descend from it.
- Decided
- Dec 27, 2000
- Review
- 78 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 0
77 later devices descend from it, 6 citing it directly.
- This deviceK003175 Compumedics Siesta SystemCompumedics Limited · 2000
- Descendant · cites it directly · 54 of its ownK013863 Crystal Monitor Model 16Cleveland Medical Devices, Inc. · 2002
- Descendant · cites it directly · 53 of its ownK042039 Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120Cleveland Medical Devices, Inc. · 2004
- Descendant · 2 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 27 of its ownK122516 Embletta MPREmbla Systems · 2013 · Recalled
- Descendant · 4 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K013863Crystal Monitor Model 16Cleveland Medical Devices, Inc. · 2002 · cites it directly54descendants
- K042039Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120Cleveland Medical Devices, Inc. · 2004 · cites it directly53descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 2 generations on41descendants
- K122516Embletta MPREmbla Systems · 2013 · 3 generations on27descendants
- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 4 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003175 | Compumedics Siesta System | Compumedics Limited | 2000 | — |
| +1 | K013863 | Crystal Monitor Model 16 | Cleveland Medical Devices, Inc. | 2002 | — |
| +1 | K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120 | Cleveland Medical Devices, Inc. | 2004 | — |
| +2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +3 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| +4 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 10 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (77)
See all 776 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013863 | Crystal Monitor Model 16 | 2002 | 54 |
| K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120 | 2004 | 53 |
| K060708 | Somnoscreen | 2007 | 11 |
| K033475 | Wireless Input Unit, Model Wee-1000A Series | 2004 | 9 |
| K103140 | Nicolet Wireless Eeg | 2011 | 7 |
| K093223 | Compumedics Grael System, Models: Grael, Grael Ecg | 2010 | 1 |
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, K013863 (Cleveland Medical Devices, Inc., 2002) has gone furthest, with 54 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 | — |
https://510kreport.com/device/K003175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003175: Compumedics Siesta System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003175
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026