510(k) Report

510(k) · Cleared

Cleared

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K970436510(k) TraditionalCleared Aug 15, 1997191-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

Natural Herbal Products, Inc. · GZO Device, Galvanic Skin Response Measurement

Cleared on Aug 15, 1997 after a 191-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Aug 15, 1997
Review
191 days
Class
Class II
Product code
GZO
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K970436Source: FDA 510(k) database · 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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.

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—

What is it indicated for?

Galvanic Skin Resistance Measurement

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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/K970436 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970436: E-Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970436

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026