510(k) · Cleared
ClearedSudoC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ld Technology, LLC · GZO Device, Galvanic Skin Response Measurement
Cleared on Sep 24, 2015 as substantially equivalent to K131568 (Ld Technology, LLC, 2013) after a 48-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Sep 24, 2015
- Review
- 48 days
- Class
- Class II
- Product code
- GZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K874850 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK874850 Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp. · 1988
- 4 generations backK032935 Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003
- 3 generations backK100233 SudoscanImpeto Medical · 2010
- 2 generations backK102166 Electro Interstitial ScanLd Technology, LLC · 2010
- 1 generation backK131568 Sudo PathLd Technology, LLC · 2013
- This deviceK152216 SudoCLd Technology, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874850 | Epi-Scan Selective Tissue Conductance Meter | Epi-Scan Corp. | 1988 | — |
| −4 | K032935 | Epi-Scan, Model P 100 | Edx Epi-Scan, Inc. | 2003 | — |
| −3 | K100233 | Sudoscan | Impeto Medical | 2010 | — |
| −2 | K102166 | Electro Interstitial Scan | Ld Technology, LLC | 2010 | — |
| −1 | K131568 | Sudo Path | Ld Technology, LLC | 2013 | — |
| 0 (this device) | K152216 | SudoC | Ld Technology, LLC | 2015 | — |
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 |
|---|---|---|---|
| * | K131568 | Sudo PathSummary page 4…Fax: 305 397 1115 Email: [email protected] 3. Predicate legally marketed (unmodified) device Trade name: SudoPath, Common name: Galvanic skin response 510K number K131568 Applicant and Manufacturer: LD TECHNOLOGY LLC (Same as new device) Product code GZO. 4. Intended use SudoC is a Galvanic skin re… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a 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. 2015, 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?
SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers.
The device is indicated for use in general adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152216: SudoC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152216
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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