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Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed As Chlor-Xtra

by Inter-Med, Inc.

510(k) K082470

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK082470 Date3 Apr 2009ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0013-2020 FDA Class II initiated 27 Jun 2019
    • Terminated Z-0015-2020 FDA Class II initiated 27 Jun 2019
    • Terminated Z-0016-2020 FDA Class II initiated 27 Jun 2019
    • Terminated Z-0017-2020 FDA Class II initiated 27 Jun 2019
    • Terminated Z-0012-2020 FDA Class II initiated 27 Jun 2019
    • Terminated Z-0014-2020 FDA Class II initiated 27 Jun 2019
    • Terminated Z-0011-2020 FDA Class II initiated 27 Jun 2019

    The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.

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  • Withdrawn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
KJJ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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