# K070069: Zipprep Electrode

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Feb 5, 2007 after 28 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 K761301 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940802: Zipprep Electrode, Aspect Medical Systems, Inc. (1994) Summary page 1.
- K961821: Aspect Medical Systems Zipprep Eeg Sensor, Aspect Medical Systems, Inc. (1996) Summary page 1.

## Indications for use
The Zipprep Electrode is applied directly to the patient's skin to enable recording of physiological signals.

Source page: https://510kreport.com/device/K070069
Methodology: https://510kreport.com/methodology