# K013863: Crystal Monitor Model 16

- Pathway: 510(k) (Traditional)
- Applicant: Cleveland Medical Devices, Inc.
- Decided: Feb 19, 2002 after 90 days
- Product code: OMC (Reduced- Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001110 (2000). 2 ancestors in all.
54 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001110: Crystal-Eeg Model 15, Cleveland Medical Devices, Inc. (2000) Summary page 1.
- K003175: Compumedics Siesta System, Compumedics Limited (2000) Summary page 1.

## Most influential descendants
- K042039: Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120 (2004), 53 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K122516: Embletta MPR (2013), 27 descendants of its own
- K161579: Watch-PAT200U (2017), 20 descendants of its own
- K180775: Watch-PAT300 (2018), 12 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K013863
Methodology: https://510kreport.com/methodology