510(k) · Cleared
Recalled · Class II · 2015Zyto Hand Cradle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zyto Technologies, Inc. · GZO Device, Galvanic Skin Response Measurement
Cleared on Aug 30, 2011 as substantially equivalent to K943101 (Global Ent., 1995) after a 112-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 2 times.
- Decided
- Aug 30, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- GZO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943101 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK943101 Galvanic Skin Response DeviceGlobal Ent. · 1995
- This deviceK111308 Zyto Hand CradleZyto Technologies, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943101 | Galvanic Skin Response Device | Global Ent. | 1995 | — |
| 0 (this device) | K111308 | Zyto Hand Cradle | Zyto Technologies, Inc. | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943101 | Galvanic Skin Response DeviceSummary page 1…Classification Name: GZO Legally Marketed Predicate Device(s) I510(k) Numberl Product Code Trade Name Applicant K943101 GZO ~ GALVANIC SKINGLBLET K943 101GZO RESPONSE DEVICEGLBLET Device Description… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2015 | Class II | Z-2120-2016 | Labeling False and Misleading | 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 | Labeling False and Misleading | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All GZO devicesGZO Device, Galvanic Skin Response Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GZO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · GZO
Too few GZO 510(k)s in any year since 2007 to give a median.
Recalls per year · GZO
No recall names GZO since 2007.
Adverse event reports per year · GZO
2in 2024
MAUDE reports naming product code GZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The measurement of Galvanic Skin Response
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111308: Zyto Hand Cradle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111308
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026