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Pensar Medical, LLC

FDA Regulatory Profile

Pensar Medical, LLC has 0 FDA recalls, 4 inspections, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
Apr 28, 2026 · OAI
Latest 510(k)
Oct 23, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 28, 2026Houston, TXDevicesOfficial Action Indicated (OAI)3007793449
Feb 16, 2023Houston, TXDevicesVoluntary Action Indicated (VAI)3007793449
Mar 11, 2016Houston, TXDevicesVoluntary Action Indicated (VAI)3007793449
Sep 12, 2012Houston, TXDevicesVoluntary Action Indicated (VAI)3007793449

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
K200223PocketDoc™ Micro Wound Therapy SystemOct 23, 2020
K150960WoundPro Negative Pressure Wound Therapy SystemDec 1, 2016

FDA data resources