510(k) · Cleared
ClearedSudoscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impeto Medical · GZO Device, Galvanic Skin Response Measurement
Cleared on Jun 14, 2010 as substantially equivalent to K032935 (Edx Epi-Scan, Inc., 2003) after a 139-day review. Its family tree reaches back 2 generations to 1988. 5 later devices descend from it.
- Decided
- Jun 14, 2010
- Review
- 139 days
- Class
- Class II
- Product code
- GZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K874850 (1988). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK874850 Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp. · 1988
- 1 generation backK032935 Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003
- This deviceK100233 SudoscanImpeto Medical · 2010
- Descendant · cites it directly · 2 of its ownK102166 Electro Interstitial ScanLd Technology, LLC · 2010
- Descendant · cites it directly · 1 of its ownK141872 SudoscanImpeto Medical, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK131568 Sudo PathLd Technology, LLC · 2013
- Descendant · cites it directly · 0 of its ownK150804 QBioScanMedeia, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK152216 SudoCLd Technology, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K102166Electro Interstitial ScanLd Technology, LLC · 2010 · cites it directly2descendants
- K141872SudoscanImpeto Medical, Inc. · 2014 · cites it directly1descendant
- K131568Sudo PathLd Technology, LLC · 2013 · 2 generations on1descendant
- K150804QBioScanMedeia, Inc. · 2015 · cites it directly0descendants
- K152216SudoCLd Technology, LLC · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874850 | Epi-Scan Selective Tissue Conductance Meter | Epi-Scan Corp. | 1988 | — |
| −1 | K032935 | Epi-Scan, Model P 100 | Edx Epi-Scan, Inc. | 2003 | — |
| 0 (this device) | K100233 | Sudoscan | Impeto Medical | 2010 | — |
| +1 | K102166 | Electro Interstitial Scan | Ld Technology, LLC | 2010 | — |
| +1 | K141872 | Sudoscan | Impeto Medical, Inc. | 2014 | — |
| +2 | K131568 | Sudo Path | Ld Technology, LLC | 2013 | — |
| +1 | K150804 | QBioScan | Medeia, Inc. | 2015 | — |
| +3 | K152216 | SudoC | Ld Technology, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K032935 | Epi-Scan, Model P 100Summary page 1…ation: 882.1 540 3. Legally Marketed Predicate Device(s) The Impeto Medical SUDOSCAN device is substantially equivalent to the EDX Epi-Scan device cleared under 510(k) K03293 5. Page I of 4 510(k) Number Product Code Trade Nam… | 2003 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102166 (Ld Technology, LLC, 2010) has gone furthest, with 2 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. 2010, 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 SudoScan system is a medical device for the measurement of galvanic skin responses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100233: Sudoscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100233
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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