510(k) · Cleared
ClearedEpi-Scan, Model P 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edx Epi-Scan, Inc. · GZO Device, Galvanic Skin Response Measurement
Cleared on Nov 20, 2003 as substantially equivalent to K874850 (Epi-Scan Corp., 1988) after a 59-day review. Its family tree reaches back 1 generation to 1988. 6 later devices descend from it.
- Decided
- Nov 20, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- GZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874850 (1988). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK874850 Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp. · 1988
- This deviceK032935 Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK100233 SudoscanImpeto Medical · 2010
- Descendant · 2 generations on · 2 of its ownK102166 Electro Interstitial ScanLd Technology, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK141872 SudoscanImpeto Medical, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK131568 Sudo PathLd Technology, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK150804 QBioScanMedeia, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100233SudoscanImpeto Medical · 2010 · cites it directly5descendants
- K102166Electro Interstitial ScanLd Technology, LLC · 2010 · 2 generations on2descendants
- K141872SudoscanImpeto Medical, Inc. · 2014 · 2 generations on1descendant
- K131568Sudo PathLd Technology, LLC · 2013 · 3 generations on1descendant
- K150804QBioScanMedeia, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874850 | Epi-Scan Selective Tissue Conductance Meter | Epi-Scan Corp. | 1988 | — |
| 0 (this device) | K032935 | Epi-Scan, Model P 100 | Edx Epi-Scan, Inc. | 2003 | — |
| +1 | K100233 | Sudoscan | Impeto Medical | 2010 | — |
| +2 | K102166 | Electro Interstitial Scan | Ld Technology, LLC | 2010 | — |
| +2 | K141872 | Sudoscan | Impeto Medical, Inc. | 2014 | — |
| +3 | K131568 | Sudo Path | Ld Technology, LLC | 2013 | — |
| +2 | K150804 | QBioScan | Medeia, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K874850 | Epi-Scan Selective Tissue Conductance MeterSummary page 1…lvanic Skin Response Measurement Device The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: K874850, Epi-Scan Selective Tissue Conductance Meter submitted by EDX Epi-Scan Inc Description of the device: The dev… | 1988 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100233 | Sudoscan | 2010 | 5 |
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?
- Its one ancestor has no recall.
- Of its descendants, K100233 (Impeto Medical, 2010) has gone furthest, with 5 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.
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?
For the measurement of galvanic skin response.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032935 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032935: Epi-Scan, Model P 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032935
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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