Atlas FDA

FRA

36 FDA 510(k) clearances · Product code

190 daysmedian time to decision
399 days90th percentile
36clearances measured

FDA profile

Official device name
Purifier, Air, Ultraviolet, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6500
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1 · 1994: 1 · 1997: 1 · 2001: 1 · 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Zener® (model ZEN-001-B1) (K252128)Uvx, Inc.2025-09-15
ViroZap Indoor Air Purifier, In Duct Model 1008 (K241140)Applied Photonix, LLC2024-08-01
AirKEE T900 (K232642)Healkee Medical Pte, Ltd.2024-05-23
AirKEE P900 (K232933)Healkee Medical Pte, Ltd.2024-05-16
Airgle Room Air Purifier (K232645)Airgle Corporation2024-02-16
Synexis Sphere Rx (K221540)Synexis, LLC2023-06-14
RGS; RGS Mini (K222702)Genesis Air, Inc.2023-06-02
Purgo (K223328)Aeroclean Technologies, Inc.2022-11-30
Purgo (K213753)Aeroclean Technologies, LLC2022-06-01
Aura Storm (K212644)Invictus Lighting2022-05-26
Bluezone Model RX-450 Air Purifier (K212824)Bluezone Products, Inc.2022-02-17
CUBE Air Purifier (K211139)Samsung Electronics Co., Ltd.2021-11-26
Molekule Air Pro (K211194)Molekule, Inc.2021-08-20
EOS Air Cleaner (K202766)Guangzhou Ajax Medical Equipment Co., Ltd.2021-06-11
Molekule Air Mini, Molekule Air Mini + (K202339)Molekule, Inc.2021-02-23
AEROCURE-MD (K203189)Aerobiotix, Inc.2021-01-21
Aerus Medical Guardian,model F170A (K201220)Aerus Medical, LLC2020-06-17
Molekule Air Pro RX (K200500)Molekule, Inc.2020-04-15
Transformair Indoor Air Purifier (K161468)Transformair, LLC2017-02-08
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI (K133800)Hgi Industires2014-12-19
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 (K062716)Eco-Rx, Inc.2006-10-27
ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P (K052732)Abracair, Inc.2006-02-24
ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER (K033448)John Mfg., Ltd.2004-07-12
AIROCIDE TI02 (K023830)Kes Science & Technology, Inc.2003-02-04
SECOND WIND AIR PURIFIER (K980745)Monagan Ent., Inc.1999-04-02
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV (K972064)Biological Controls, Inc.1997-12-01
VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM (K954448)Schiff & Co.1996-10-28
VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM (K960833)Uv Technologies, Inc.1996-07-25
RXAIR 3000 (K951981)Clean Air Research & Development1995-10-12
VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE (K943521)Schiff & Co.1995-02-14
DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM (K933454)L&H Airco1994-09-16
CLESTRACLEAN(R) ROOM AIR PURIFIER (K932803)Clestra Cleanroom Technology, Inc.1994-05-12
ICS 9400 ULTRAVIOLET AIR PURIFIER (K934914)Medair, Inc.1994-04-13
STRAIGHT-LINES I.V. ORGANIZER (K920965)Taylor Bio-Medical, Inc.1993-04-07
UV AIR STERILIGHT (K884579)Allseasons Environmental Control, Inc.1988-12-12
AIR CARE AIR SANITIZER (K860132)Cooper-Hewitt Electric Co.1987-01-13

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