# K111308: Zyto Hand Cradle

- Pathway: 510(k) (Traditional)
- Applicant: Zyto Technologies, Inc.
- Decided: Aug 30, 2011 after 112 days
- Product code: GZO (Device, Galvanic Skin Response Measurement)
- Device class: 2
- Regulation: 21 CFR 882.1540
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943101 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943101: Galvanic Skin Response Device, Global Ent. (1995) Summary page 1.

## Recalls of this device
- Nov 23, 2015 · Class II · Z-2120-2016: ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
- Nov 23, 2015 · Class II · Z-2121-2016: ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

## Indications for use
The measurement of Galvanic Skin Response

Source page: https://510kreport.com/device/K111308
Methodology: https://510kreport.com/methodology