# K050313: Bis SRS (Semi-Resuable Sensor)

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Feb 24, 2005 after 15 days
- Product code: GWY (Pinwheel)
- Device class: 1
- Regulation: 21 CFR 882.1750
- 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 K940802 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- K940802: Zipprep Electrode, Aspect Medical Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K091854: Bis Click Sensor/Cable (2009), 0 descendants of its own

## Indications for use
The Aspect Medical Systems Semi-Reusable Sensor is applied directly to the patient’s skin to enable recordings of electrophysiological (such as EEG) signals.

Source page: https://510kreport.com/device/K050313
Methodology: https://510kreport.com/methodology