510(k) · Cleared
ClearedFamily of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleveland Medical Devices, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Nov 17, 2004 as substantially equivalent to K013863 (Cleveland Medical Devices, Inc., 2002) and 1 other predicate after a 111-day review. Its family tree reaches back 2 generations to 2000. 53 later devices descend from it.
- Decided
- Nov 17, 2004
- Review
- 111 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001110 (2000). 3 ancestors in all. 53 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001110 Crystal-Eeg Model 15Cleveland Medical Devices, Inc. · 2000
- 1 generation backK013863 Crystal Monitor Model 16Cleveland Medical Devices, Inc. · 2002
- This deviceK042039 Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120Cleveland Medical Devices, Inc. · 2004
- Descendant · cites it directly · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 27 of its ownK122516 Embletta MPREmbla Systems · 2013 · Recalled
- Descendant · 3 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · 4 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- Descendant · cites it directly · 10 of its ownK063872 KinesiaCleveland Medical Devices, Inc. · 2007
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K073682Embletta GoldEmbla Systems, Inc. · 2008 · cites it directly41descendants
- K122516Embletta MPREmbla Systems · 2013 · 2 generations on27descendants
- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 3 generations on20descendants
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 4 generations on12descendants
- K063872KinesiaCleveland Medical Devices, Inc. · 2007 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001110 | Crystal-Eeg Model 15 | Cleveland Medical Devices, Inc. | 2000 | — |
| −1 | K013863 | Crystal Monitor Model 16 | Cleveland Medical Devices, Inc. | 2002 | — |
| 0 (this device) | K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120 | Cleveland Medical Devices, Inc. | 2004 | — |
| +1 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +2 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| +3 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +4 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| +1 | K063872 | Kinesia | Cleveland Medical Devices, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 10 | 0 |
| 2026 | 8 | 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 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? (2)
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 |
|---|---|---|---|
| * | K013863 | Crystal Monitor Model 16Summary page 1…land, Ohio 44103 (216) 791-6720 (216) 791-6739 Date July 26, 2004 Name Robert N. Schmidt, President Classification 882.1400 Predicate: Crystal Monitor Mode! 16, K013863 and Siesta System, K003175 Description: The Family of Crystal 20 Monitors® are designed to monitor physiological signals such a… | 2002 |
| * | K003175 | Compumedics Siesta SystemSummary page 1…-6720 (216) 791-6739 Date July 26, 2004 Name Robert N. Schmidt, President Classification 882.1400 Predicate: Crystal Monitor Mode! 16, K013863 and Siesta System, K003175 Description: The Family of Crystal 20 Monitors® are designed to monitor physiological signals such as cardiovascular, neurologi… | 2000 |
What descends from it? (53)
See all 532 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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073682 (Embla Systems, Inc., 2008) has gone furthest, with 41 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 Family of Crystal 20 Monitors are intended for monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.
The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
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/K042039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042039: Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042039
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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