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Cardiac Designs, LLC

FDA Regulatory Profile

Cardiac Designs, LLC has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 1 compliance action on record.

Latest inspection
Jun 29, 2016 · VAI
Latest 510(k)
Oct 2, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 29, 2016Round Rock, TXDevicesVoluntary Action Indicated (VAI)3010665082

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
K170506ECG Check - Universal, ECG Check - Universal PlusOct 2, 2017
K131045ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWAREMay 29, 2013
K122184ECG CHECKFeb 14, 2013

FDA data resources