510(k) · Cleared
ClearedSudo Path
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 Jun 28, 2013 as substantially equivalent to K102166 (Ld Technology, LLC, 2010) after a 29-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Jun 28, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- GZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K874850 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK874850 Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp. · 1988
- 3 generations backK032935 Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003
- 2 generations backK100233 SudoscanImpeto Medical · 2010
- 1 generation backK102166 Electro Interstitial ScanLd Technology, LLC · 2010
- This deviceK131568 Sudo PathLd Technology, LLC · 2013
- Descendant · cites it directly · 0 of its ownK152216 SudoCLd Technology, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K152216SudoCLd Technology, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874850 | Epi-Scan Selective Tissue Conductance Meter | Epi-Scan Corp. | 1988 | — |
| −3 | K032935 | Epi-Scan, Model P 100 | Edx Epi-Scan, Inc. | 2003 | — |
| −2 | K100233 | Sudoscan | Impeto Medical | 2010 | — |
| −1 | K102166 | Electro Interstitial Scan | Ld Technology, LLC | 2010 | — |
| 0 (this device) | K131568 | Sudo Path | Ld Technology, LLC | 2013 | — |
| +1 | K152216 | SudoC | Ld Technology, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 |
|---|---|---|---|
| * | K102166 | Electro Interstitial ScanSummary page 1…Fax: 305397 1115 Email: [email protected] 3. Predicate legally marketed (unmodified) device Trade name: EIS-GS, Common name: Galvanic skin response 510K number K102166 Applicant and Manufacturer: LD TECHNOLOGY LLC (Same as new device SudoPath) Product code GZO. 4. Intended use . SudoPath is a G… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152216 | SudoC | 2015 | 0 |
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 25 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152216 (Ld Technology, LLC, 2015) has gone furthest, with 0 descendants of its own.
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. 2013, 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?
SudoPath device is a medical device for the measurement of galvanic skin response.
The SudoPath 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131568: Sudo Path.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131568
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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