510(k) · Cleared

Cleared

QBioScan

K150804510(k) TraditionalCleared Oct 19, 2015207-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

Medeia, Inc. · GZO Device, Galvanic Skin Response Measurement

Cleared on Oct 19, 2015 as substantially equivalent to K100233 (Impeto Medical, 2010) and 1 other predicate after a 207-day review. Its family tree reaches back 4 generations to 1988.

Decided: Oct 19, 2015
Review: 207 days
Class: Class II
Product code: GZO
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K874850 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK874850 Epi-Scan Selective Tissue Conductance MeterEpi-Scan Corp. · 1988
3 generations backK032935 Epi-Scan, Model P 100Edx Epi-Scan, Inc. · 2003
2 generations backK100233 SudoscanImpeto Medical · 2010
1 generation backK141872 SudoscanImpeto Medical, Inc. · 2014
This deviceK150804 QBioScanMedeia, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K874850	Epi-Scan Selective Tissue Conductance Meter	Epi-Scan Corp.	1988	—
−3	K032935	Epi-Scan, Model P 100	Edx Epi-Scan, Inc.	2003	—
−2	K100233	Sudoscan	Impeto Medical	2010	—
−1	K141872	Sudoscan	Impeto Medical, Inc.	2014	—
0 (this device)	K150804	QBioScan	Medeia, Inc.	2015	—

FIG. 1 — Lineage of K150804, 1988–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K100233	Sudoscan Summary page 4 …ation Name: Galvanic Skin Measurement Device (21 CFR 882.1540 / GZO) a3 PREDICATE DEVICE: Device Name: Sudoscan K Numbers: K100233 and K141872 Manufacturer: Impeto Medical 17, rue Campagne Première…	Impeto Medical	2010	—
*	K141872	Sudoscan Summary page 4 …Galvanic Skin Measurement Device (21 CFR 882.1540 / GZO) a3 PREDICATE DEVICE: Device Name: Sudoscan K Numbers: K100233 and K141872 Manufacturer: Impeto Medical 17, rue Campagne Première…	Impeto Medical, Inc.	2014	—

Also cleared against K100233: 2 other devices →

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.

What does this lineage say?

The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K100233.

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. 2015, this device’s year, is highlighted.

FDA decisions per year · GZO

2in 2015

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	1
2009	0	—	0
2010	2	—	1
2011	1	—	0
2012	0	—	1
2013	1	—	0
2014	1	—	1
2015	2	—	0
2016	0	—	0
2017	0	—	1
2018	0	—	19
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	2
2025	0	—	0
2026	0	—	—

What is it indicated for?

QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function.

The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150804: QBioScan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150804

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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