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Caphosol® Artifical Saliva (32 doses sachet box)

by Eusa Pharma (Uk) Limited

510(k) K234015

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 NumberK234015 Date11 Mar 2024ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2012-2025 FDA Class II initiated 11 Jun 2025

    Out of specification stability test result for the Caphosol B solution from process validation lots

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  • Withdrawn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

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