510(k) · Cleared
ClearedSudoscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impeto Medical, Inc. · GZO Device, Galvanic Skin Response Measurement
Cleared on Nov 21, 2014 as substantially equivalent to K100233 (Impeto Medical, 2010) after a 133-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Nov 21, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- GZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874850 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK874850 Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp. · 1988
- 2 generations backK032935 Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003
- 1 generation backK100233 SudoscanImpeto Medical · 2010
- This deviceK141872 SudoscanImpeto Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK150804 QBioScanMedeia, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150804QBioScanMedeia, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874850 | Epi-Scan Selective Tissue Conductance Meter | Epi-Scan Corp. | 1988 | — |
| −2 | K032935 | Epi-Scan, Model P 100 | Edx Epi-Scan, Inc. | 2003 | — |
| −1 | K100233 | Sudoscan | Impeto Medical | 2010 | — |
| 0 (this device) | K141872 | Sudoscan | Impeto Medical, Inc. | 2014 | — |
| +1 | K150804 | QBioScan | Medeia, Inc. | 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 |
|---|---|---|---|
| * | K100233 | SudoscanSummary page 4…II Panel: Neurology Product Code: GZO Date Prepared: July 7, 2014 Predicate Device: K100233, SUDOSCAN, IMPETO Medical Indication for Use: The SUDOSCAN system is a medical device for the measurement of galvanic skin resp… | 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 |
|---|---|---|---|
| K150804 | QBioScan | 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 26 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150804 (Medeia, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100233.
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. 2014, 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 response to aid in the assessment of sudomotor function.
SUDOSCAN is indicated for use in the general adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141872: Sudoscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141872
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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