# K940802: Zipprep Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Jun 22, 1994 after 120 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961821: Aspect Medical Systems Zipprep Eeg Sensor (1996), 13 descendants of its own
- K994330: Aspect Medical Systems Eeg Sensor, Model 186-0076 (2000), 11 descendants of its own
- K013389: Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories (2002), 10 descendants of its own
- K023459: Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories (2003), 8 descendants of its own
- K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories (2005), 7 descendants of its own

Source page: https://510kreport.com/device/K940802
Methodology: https://510kreport.com/methodology