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Respire Medical Holdings

FDA Regulatory Profile

Respire Medical Holdings has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Oct 25, 2022 · VAI
Latest 510(k)
Feb 5, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections6Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 25, 2022Brooklyn, NYDevicesVoluntary Action Indicated (VAI)3008937561
Aug 15, 2019Brooklyn, NYDevicesVoluntary Action Indicated (VAI)3008937561
May 2, 2018Brooklyn, NYDevicesVoluntary Action Indicated (VAI)3008937561
Nov 22, 2016Brooklyn, NYDevicesNo Action Indicated (NAI)3008937561
Jan 16, 2014Brooklyn, NYDevicesNo Action Indicated (NAI)3008937561
Nov 18, 2011Brooklyn, NYDevicesNo Action Indicated (NAI)3008937561

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
K192127Respire Pink AT (Hard, Hard/Soft, EF)Feb 5, 2020

FDA data resources