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Freedom Mark III Surgical Helmet System

by Stackhouse Assoc.

510(k) K910515

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 · Traditional NumberK910515 Date6 May 1991ClearedStatusActive

Recalls

15 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-1347-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1338-2015 FDA Class II initiated 10 Mar 2015
    • Terminated Z-1339-2015 FDA Class II initiated 10 Mar 2015
    • Terminated Z-1349-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1346-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1343-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1340-2015 FDA Class II initiated 10 Mar 2015
    • Terminated Z-1344-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1345-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1342-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1341-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1348-2015 FDA Class II initiated 10 Mar 2015 on shared 510(k) K910515
    • Terminated Z-1337-2015 FDA Class II initiated 10 Mar 2015

    This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

  • 2 recalls, same reason

    • Terminated Z-0002-06 FDA Unclassified (pre-2012) initiated 13 Sep 2005 on shared 510(k) K910515
    • Terminated Z-0001-06 FDA Unclassified (pre-2012) initiated 13 Sep 2005 on shared 510(k) K910515

    The packaging may be compromised such that sterility of the hoods cannot be guaranteed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
FYA
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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