# K062692: Bis Bilateral Sensor

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Dec 13, 2006 after 93 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002734 (2000). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002734: Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106, Aspect Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K143506: Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes; Bis Quatro Sensor; Bis Pedi-XP Sensor,2-Channel (4 Electrodes); Bis Extend Sensor; Bis Bilateral Sensor,4-Channel (6 Elecrodes); Bis Insight Sensor,Cvi-Enabled,2-Channel (4 Electrodes) (2015), 4 descendants of its own
- K220448: Disposable Non-invasive EEG Sensor (2023), 1 descendant of its own
- K151576: Neon EEG (2015), 1 descendant of its own
- K243788: IceCap product line (2025), 0 descendants of its own
- K241160: CAIs Sensor (CAIs-001) (2024), 0 descendants of its own

## Recalls of this device
- Nov 8, 2011 · Not classified · Z-0802-2012: During manufacture, circuit traces were reversed which causes inaccurate display of information.

## Indications for use
The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

Source page: https://510kreport.com/device/K062692
Methodology: https://510kreport.com/methodology