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Saline Wound Wash

by Nanoplas, Inc.

510(k) K112666

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

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 NumberK112666 Date20 Apr 2012ClearedStatusActive

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1435-2026 FDA Class II initiated 5 Jan 2026
    • Ongoing Z-1431-2026 FDA Class II initiated 5 Jan 2026
    • Ongoing Z-1432-2026 FDA Class II initiated 5 Jan 2026 on shared 510(k) K112666
    • Ongoing Z-1433-2026 FDA Class II initiated 5 Jan 2026 on shared 510(k) K112666
    • Ongoing Z-1434-2026 FDA Class II initiated 5 Jan 2026 on shared 510(k) K112666

    Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

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  • Withdrawn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