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Babyation, LLC

FDA Regulatory Profile

Babyation, LLC has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
May 28, 2026 · VAI
Latest 510(k)
Apr 4, 2018

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 28, 2026Saint Louis, MODevicesVoluntary Action Indicated (VAI)3015200642
Oct 13, 2022Saint Louis, MODevicesVoluntary Action Indicated (VAI)3015200642

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
K173699The Pump by BabyationApr 4, 2018

FDA data resources