Home / 510(k) Clearances / K223835

510(k) K223835

MA-40, MA-112 by Medify Air, LLC — Product Code FRF

K223835 is an FDA 510(k) premarket notification submitted by Medify Air, LLC for the device "MA-40, MA-112". The FDA issued a decision of Substantially Equivalent on September 18, 2023. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2023
Date Received
December 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

Other clearances for product code FRF

  • K251872 — Biomoneta Avata Rx (November 14, 2025)
  • K242102 — CerroZone Mini (November 19, 2024)
  • K240696 — Airdog X8 Air Purifier (KJ800F-X8) (June 14, 2024)
  • K222416 — RIA Safeguard (May 1, 2023)
  • K211507 — Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (November 22, 2022)
  • K220990 — Qorda QD1 (September 14, 2022)
  • K220298 — CerroZone Mobile (July 1, 2022)
  • K200321 — Novaerus NV1050 (December 28, 2020)
  • K130702 — AIRSONETT AIR-4 (July 23, 2013)
  • K112728 — HEPAIRX VENTILATING AIR PURIFIER (January 23, 2013)

FDA data resources