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Inovel Health Care Model N95 Particulate Respirators and Surgical Masks

by Inovel, LLC

510(k) K051182

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK051182 Date19 May 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0587-06 FDA Unclassified (pre-2012) initiated 20 Feb 2006

    Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MSH
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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