FRA · Class II · 21 CFR 880.6500

FDA Product Code FRA: Purifier, Air, Ultraviolet, Medical

Leading manufacturers include Molekule, Inc., Healkee Medical Pte, Ltd. and Airgle Corporation.

36
Total
36
Cleared
209d
Avg days
1987
Since
Declining activity - 2 submissions in the last 2 years vs 6 in the prior period
Review times improving: avg 85d recently vs 217d historically

FDA 510(k) Cleared Purifier, Air, Ultraviolet, Medical Devices (Product Code FRA)

36 devices
1–24 of 36
Cleared Sep 15, 2025
Zener® (model ZEN-001-B1)
K252128
Uvx, Inc.
General Hospital · 70d
Cleared Aug 01, 2024
ViroZap Indoor Air Purifier, In Duct Model 1008
K241140
Applied Photonix, LLC
General Hospital · 99d
Cleared May 23, 2024
AirKEE T900
K232642
Healkee Medical Pte, Ltd.
General Hospital · 267d
Cleared May 16, 2024
AirKEE P900
K232933
Healkee Medical Pte, Ltd.
General Hospital · 239d
Cleared Feb 16, 2024
Airgle Room Air Purifier
K232645
Airgle Corporation
General Hospital · 170d
Cleared Jun 14, 2023
Synexis Sphere Rx
K221540
Synexis, LLC
General Hospital · 383d
Cleared Jun 02, 2023
RGS
K222702
Genesis Air, Inc.
General Hospital · 268d
Cleared Nov 30, 2022
Purgo
K223328
Aeroclean Technologies, Inc.
General Hospital · 30d
Cleared Jun 01, 2022
Purgo
K213753
Aeroclean Technologies, LLC
General Hospital · 183d
Cleared May 26, 2022
Aura Storm
K212644
Invictus Lighting
General Hospital · 279d
Cleared Feb 17, 2022
Bluezone Model RX-450 Air Purifier
K212824
Bluezone Products, Inc.
General Hospital · 167d
Cleared Nov 26, 2021
CUBE Air Purifier
K211139
Samsung Electronics Co., Ltd.
General Hospital · 224d
Cleared Aug 20, 2021
Molekule Air Pro
K211194
Molekule, Inc.
General Hospital · 121d
Cleared Jun 11, 2021
EOS Air Cleaner
K202766
Guangzhou Ajax Medical Equipment Co., Ltd.
General Hospital · 263d
Cleared Feb 23, 2021
Molekule Air Mini, Molekule Air Mini +
K202339
Molekule, Inc.
General Hospital · 190d
Cleared Jan 21, 2021
AEROCURE-MD
K203189
Aerobiotix, Inc.
General Hospital · 86d
Cleared Jun 17, 2020
Aerus Medical Guardian,model F170A
K201220
Aerus Medical, LLC
General Hospital · 42d
Cleared Apr 15, 2020
Molekule Air Pro RX
K200500
Molekule, Inc.
General Hospital · 47d

About Product Code FRA - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code FRA since 1987, with 36 receiving FDA clearance (average review time: 209 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 6 in the prior period.

FDA 510(k) Review Time - FRA Product Code

Recent submissions under FRA have taken an average of 85 days to reach a decision - down from 217 days historically, suggesting improved FDA processing for this classification.

FRA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →