510(k) · Cleared
ClearedCrystal Monitor Model 16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleveland Medical Devices, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Feb 19, 2002 as substantially equivalent to K001110 (Cleveland Medical Devices, Inc., 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2000. 54 later devices descend from it.
- Decided
- Feb 19, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001110 (2000). 2 ancestors in all. 54 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001110 Crystal-Eeg Model 15Cleveland Medical Devices, Inc. · 2000
- This deviceK013863 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
- Descendant · 5 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- 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
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001110 | Crystal-Eeg Model 15 | Cleveland Medical Devices, Inc. | 2000 | — |
| 0 (this device) | 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 | — |
| +5 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 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 |
|---|---|---|---|
| * | K001110 | Crystal-Eeg Model 15Summary page 1…16 Common Name: Electroencephalograph Classification: Class Il per regulations 882.1400 Product Codes: Op(, ) oL/ Equivalent Devices: Crystal EEG Model 15, 510(k) No. K001110 Compumedics Siesta System, 510(k) No. K003175 Description: The Crystal Monitor Model 16 is an eight-channel, programmable, wirel… | 2000 |
| * | K003175 | Compumedics Siesta SystemSummary page 1…ication: Class Il per regulations 882.1400 Product Codes: Op(, ) oL/ Equivalent Devices: Crystal EEG Model 15, 510(k) No. K001110 Compumedics Siesta System, 510(k) No. K003175 Description: The Crystal Monitor Model 16 is an eight-channel, programmable, wireless data acquisition system intended to monito… | 2000 |
What descends from it? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120 | 2004 | 53 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K042039 (Cleveland Medical Devices, Inc., 2004) has gone furthest, with 53 descendants of its own.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Crystal Monitoré Model 16 is intended for wireless 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/K013863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013863: Crystal Monitor Model 16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013863
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026