510(k) Report

510(k) · Cleared

Cleared

Epi-Scan Selective Tissue Conductance Meter

K874850510(k) TraditionalCleared May 20, 1988169-day reviewClass II21 CFR 882.1540

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Epi-Scan Corp. · GZO Device, Galvanic Skin Response Measurement

Cleared on May 20, 1988 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
May 20, 1988
Review
169 days
Class
Class II
Product code
GZO
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2010: 2 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK874850 Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp. · 1988
  2. Descendant · cites it directly · 6 of its ownK032935 Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003
  3. Descendant · 2 generations on · 5 of its ownK100233 SudoscanImpeto Medical · 2010
  4. Descendant · 3 generations on · 2 of its ownK102166 Electro Interstitial ScanLd Technology, LLC · 2010
  5. Descendant · 3 generations on · 1 of its ownK141872 SudoscanImpeto Medical, Inc. · 2014
  6. Descendant · 4 generations on · 1 of its ownK131568 Sudo PathLd Technology, LLC · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 12010: 22013: 12014: 12015: 2
2003high 2 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K032935Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003 · cites it directly6descendants
  • K100233SudoscanImpeto Medical · 2010 · 2 generations on5descendants
  • K102166Electro Interstitial ScanLd Technology, LLC · 2010 · 3 generations on2descendants
  • K141872SudoscanImpeto Medical, Inc. · 2014 · 3 generations on1descendant
  • K131568Sudo PathLd Technology, LLC · 2013 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874850Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp.1988—
+1K032935Epi-Scan, Model P 100Edx Epi-Scan, Inc.2003—
+2K100233SudoscanImpeto Medical2010—
+3K102166Electro Interstitial ScanLd Technology, LLC2010—
+3K141872SudoscanImpeto Medical, Inc.2014—
+4K131568Sudo PathLd Technology, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201020
201310
201410
201520
FIG. 1 — Lineage of K874850, 1988–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032935Epi-Scan, Model P 100Edx Epi-Scan, Inc.20036

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?

  • Of its descendants, K032935 (Edx Epi-Scan, Inc., 2003) has gone furthest, with 6 descendants of its own.

How does its category compare?

All GZO devices

GZO Device, Galvanic Skin Response Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZO

2in 2015

2010: 22011: 12013: 12014: 12015: 2
2007high 2 (2010) · low 0 (2007)2026

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

2008: 12010: 12012: 12014: 12017: 12018: 192021: 12024: 2
2007high 19 (2018) · low 0 (2007)2025

MAUDE reports naming product code GZO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—00
20102—01
20111—00
20120—01
20131—00
20141—01
20152—00
20160—00
20170—01
20180—019
20190—00
20200—00
20210—01
20220—00
20230—00
20240—02
20250—00
20260—0—

Recent decisions in GZO

The GZO category page

  • K150804QBioScanMedeia, Inc. · 2015
  • K152216SudoCLd Technology, LLC · 2015
  • K141872SudoscanImpeto Medical, Inc. · 2014
  • K131568Sudo PathLd Technology, LLC · 2013
  • K111308Zyto Hand CradleZyto Technologies, Inc. · 20112 recalls

https://510kreport.com/device/K874850 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874850: Epi-Scan Selective Tissue Conductance Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874850

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026