# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Apr 16, 2015 after 127 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002734 (2000). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093183: Bis Quatro Sensor, Aspect Medical Systems, Inc. (2009). Our OCR of the scanned summary read K093133, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aspect Medical Systems BIS Quatro (and Extend) Sensor”.
- K062692: Bis Bilateral Sensor, Aspect Medical Systems, Inc. (2006) Summary page 4.
- K041670: Bis Pediatric Sensor, Aspect Medical Systems, Inc. (2004) Summary page 4.

## Most influential descendants
- K220448: Disposable Non-invasive EEG Sensor (2023), 1 descendant of its own
- K241160: CAIs Sensor (CAIs-001) (2024), 0 descendants of its own
- K240668: Amydi-med Disposable Non-invasive EEG electrodes (2024), 0 descendants of its own
- K222671: DeltaScan Patch (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K143506
Methodology: https://510kreport.com/methodology