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EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

by E.M.S. Electro Medical Systems S.A. Switzerland 510(k)

510(k) K190124 Product code ELC

Regulatory status

as of 25 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190124 Date20 Oct 2019ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1686-2024 FDA Class II initiated 13 Mar 2024
    • Ongoing Z-1687-2024 FDA Class II initiated 13 Mar 2024
    • Ongoing Z-1688-2024 FDA Class II initiated 13 Mar 2024

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
ELC
FDA applicant
E.M.S Electro Medical Systems S.A
Device Class
Class II
Regulation
21 CFR Part 872.4850
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from E.M.S. Electro Medical Systems S.A.

See all devices from E.M.S. Electro Medical Systems S.A. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K190124 24 fields · synced 22 Oct 2026