510(k) Report

510(k) · Cleared

Cleared

Biofind

K003480510(k) TraditionalCleared May 11, 2001183-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

Bio-Scan, Inc. · GZO Device, Galvanic Skin Response Measurement

Cleared on May 11, 2001 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 11, 2001
Review
183 days
Class
Class II
Product code
GZO
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K003480Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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—

More from Bio-Scan, Inc.

6 FDA decisions under this applicant name. See the company

  • K925735Eeg AnalyzerBio-Scan, Inc. · 1993
  • K864928Bio-Log 8+1 Ambulatory Physiologic RecorderBio-Scan, Inc. · 1987
  • K841685Eeg ElectrodesBio-Scan, Inc. · 1984
  • K841684Bio/Scan Biolog Cassette RecorderBio-Scan, Inc. · 1984
  • K841683Q.P. Preamplifier SysBio-Scan, Inc. · 1984

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/K003480 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003480: Biofind.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003480

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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