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Katalyst, Inc.

FDA Regulatory Profile

Katalyst, Inc. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 28, 2019 · NAI
Latest 510(k)
Feb 3, 2020

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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 actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 28, 2019Las Vegas, NVDevicesNo Action Indicated (NAI)3014545203

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
K190966Katalyst Training SystemFeb 3, 2020
K181199Katalyst Mark 1 Muscle Stimulation System Model 2Sep 20, 2018
K171035Katalyst Mark 1 Muscle Stimulation SystemSep 6, 2017

FDA data resources