Imaging Biometrics, LLC

FDA Regulatory Profile

Imaging Biometrics, LLC has 0 FDA recalls, 6 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 17, 2025 · NAI
Latest 510(k)
Oct 29, 2020

Reviewing Imaging Biometrics, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Imaging Biometrics, LLC's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections6Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 17, 2025Elm Grove, WIDevicesNo Action Indicated (NAI)3007225492
Jun 9, 2022Elm Grove, WIDevicesNo Action Indicated (NAI)3007225492
Oct 12, 2018Elm Grove, WIDevicesVoluntary Action Indicated (VAI)3007225492
Mar 22, 2013Elm Grove, WIDevicesVoluntary Action Indicated (VAI)3007225492
Jun 24, 2010Elm Grove, WIDevicesNo Action Indicated (NAI)3007225492
Sep 30, 2009Elm Grove, WIDevicesVoluntary Action Indicated (VAI)3007225492

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K201092LSNOct 29, 2020
K191530StoneCheckerSep 26, 2019
K123302IB CLINICJan 11, 2013
K080762IB NEURO, VERSION 1.0May 15, 2008