Panels › General Hospital › Product code FRA · Class 2
Purifier, Air, Ultraviolet, Medical
Regulation 880.6500
0510(k)s in 12 months (36 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FRA
| Company | 510(k)s | Recalls |
|---|---|---|
| Molekule, Inc. | 3 | 0 |
| Aeroclean Technologies, Inc. | 2 | 0 |
| Healkee Medical Pte, Ltd. | 2 | 0 |
| Schiff & Co. | 2 | 0 |
| Abracair, Inc. | 1 | 0 |
| Aerobiotix, Inc. | 1 | 0 |
| Aerus Medical, LLC | 1 | 0 |
| Airgle Corporation | 1 | 0 |
| Allseasons Environmental Control, Inc. | 1 | 0 |
| Applied Photonix, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2025 | K252128 | Zener® (model ZEN-001-B1) Uvx, Inc., CA | FRA |
| Aug 1, 2024 | K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 Applied Photonix, LLC | FRA |
| May 23, 2024 | K232642 | AirKEE T900 Healkee Medical Pte, Ltd., SG | FRA |
| May 16, 2024 | K232933 | AirKEE P900 Healkee Medical Pte, Ltd., SG | FRA |
| Feb 16, 2024 | K232645 | Airgle Room Air Purifier Airgle Corporation | FRA |
| Jun 14, 2023 | K221540 | Synexis Sphere Rx Synexis, LLC | FRA |
| Jun 2, 2023 | K222702 | RGS; RGS Mini Genesis Air, Inc. | FRA |
| Nov 30, 2022 | K223328 | Purgo Aeroclean Technologies, Inc. | FRA |
| Jun 1, 2022 | K213753 | Purgo Aeroclean Technologies, LLC | FRA |
| May 26, 2022 | K212644 | Aura Storm Invictus Lighting | FRA |
| Feb 17, 2022 | K212824 | Bluezone Model RX-450 Air Purifier Bluezone Products, Inc. | FRA |
| Nov 26, 2021 | K211139 | CUBE Air Purifier Samsung Electronics Co., Ltd., KR | FRA |
| Aug 20, 2021 | K211194 | Molekule Air Pro Molekule, Inc. | FRA |
| Jun 11, 2021 | K202766 | EOS Air Cleaner Guangzhou Ajax Medical Equipment Co., Ltd., CN | FRA |
| Feb 23, 2021 | K202339 | Molekule Air Mini, Molekule Air Mini + Molekule, Inc. | FRA |
| Jan 21, 2021 | K203189 | AEROCURE-MD Aerobiotix, Inc. | FRA |
| Jun 17, 2020 | K201220 | Aerus Medical Guardian,model F170A Aerus Medical, LLC | FRA |
| Apr 15, 2020 | K200500 | Molekule Air Pro RX Molekule, Inc. | FRA |
| Feb 8, 2017 | K161468 | Transformair Indoor Air Purifier Transformair, LLC | FRA |
| Dec 19, 2014 | K133800 | ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI Hgi Industires | FRA |
| Oct 27, 2006 | K062716 | ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 Eco-Rx, Inc., CA | FRA |
| Feb 24, 2006 | K052732 | ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P Abracair, Inc. | FRA |
| Jul 12, 2004 | K033448 | ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER John Mfg., Ltd. | FRA |
| Feb 4, 2003 | K023830 | AIROCIDE TI02 Kes Science & Technology, Inc. | FRA |
| Apr 2, 1999 | K980745 | SECOND WIND AIR PURIFIER Monagan Ent., Inc. | FRA |
| Dec 1, 1997 | K972064 | MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV Biological Controls, Inc. | FRA |
| Oct 28, 1996 | K954448 | VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM Schiff & Co. | FRA |
| Jul 25, 1996 | K960833 | VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM Uv Technologies, Inc. | FRA |
| Oct 12, 1995 | K951981 | RXAIR 3000 Clean Air Research & Development | FRA |
| Feb 14, 1995 | K943521 | VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE Schiff & Co. | FRA |
| Sep 16, 1994 | K933454 | DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM L&H Airco | FRA |
| May 12, 1994 | K932803 | CLESTRACLEAN(R) ROOM AIR PURIFIER Clestra Cleanroom Technology, Inc. | FRA |
| Apr 13, 1994 | K934914 | ICS 9400 ULTRAVIOLET AIR PURIFIER Medair, Inc. | FRA |
| Apr 7, 1993 | K920965 | STRAIGHT-LINES I.V. ORGANIZER Taylor Bio-Medical, Inc. | FRA |
| Dec 12, 1988 | K884579 | UV AIR STERILIGHT Allseasons Environmental Control, Inc., CA | FRA |
| Jan 13, 1987 | K860132 | AIR CARE AIR SANITIZER Cooper-Hewitt Electric Co. | FRA |
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