FDA Product Code
FDA Product Code FRA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6500
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252128 | Zener® (model ZEN-001-B1) | Uvx, Inc. | 2025-09-15 | Traditional | PDF ↗ |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC | 2024-08-01 | Traditional | PDF ↗ |
| K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | 2024-05-23 | Traditional | PDF ↗ |
| K232933 | AirKEE P900 | Healkee Medical Pte, Ltd. | 2024-05-16 | Traditional | PDF ↗ |
| K232645 | Airgle Room Air Purifier | Airgle Corporation | 2024-02-16 | Traditional | PDF ↗ |
| K221540 | Synexis Sphere Rx | Synexis, LLC | 2023-06-14 | Traditional | PDF ↗ |
| K222702 | RGS; RGS Mini | Genesis Air, Inc. | 2023-06-02 | Traditional | PDF ↗ |
| K223328 | Purgo | Aeroclean Technologies, Inc. | 2022-11-30 | Special | PDF ↗ |
| K213753 | Purgo | Aeroclean Technologies, LLC | 2022-06-01 | Traditional | PDF ↗ |
| K212644 | Aura Storm | Invictus Lighting | 2022-05-26 | Traditional | PDF ↗ |
| K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | 2022-02-17 | Traditional | PDF ↗ |
| K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | 2021-11-26 | Traditional | PDF ↗ |
| K211194 | Molekule Air Pro | Molekule, Inc. | 2021-08-20 | Traditional | PDF ↗ |
| K202766 | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. | 2021-06-11 | Traditional | PDF ↗ |
| K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021-02-23 | Traditional | PDF ↗ |
| K203189 | AEROCURE-MD | Aerobiotix, Inc. | 2021-01-21 | Traditional | PDF ↗ |
| K201220 | Aerus Medical Guardian,model F170A | Aerus Medical, LLC | 2020-06-17 | Traditional | PDF ↗ |
| K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020-04-15 | Traditional | PDF ↗ |
| K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017-02-08 | Traditional | PDF ↗ |
| 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 | 2014-12-19 | Traditional | PDF ↗ |
| K062716 | ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 | Eco-Rx, Inc. | 2006-10-27 | Traditional | PDF ↗ |
| K052732 | ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P | Abracair, Inc. | 2006-02-24 | Traditional | PDF ↗ |
| K033448 | ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER | John Mfg., Ltd. | 2004-07-12 | Traditional | PDF ↗ |
| K023830 | AIROCIDE TI02 | Kes Science & Technology, Inc. | 2003-02-04 | Traditional | PDF ↗ |
| K980745 | SECOND WIND AIR PURIFIER | Monagan Ent., Inc. | 1999-04-02 | Traditional | PDF ↗ |
| K972064 | MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV | Biological Controls, Inc. | 1997-12-01 | Traditional | PDF ↗ |
| K954448 | VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM | Schiff & Co. | 1996-10-28 | Traditional | PDF ↗ |
| K960833 | VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM | Uv Technologies, Inc. | 1996-07-25 | Traditional | PDF ↗ |
| K951981 | RXAIR 3000 | Clean Air Research & Development | 1995-10-12 | Traditional | PDF ↗ |
| K943521 | VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE | Schiff & Co. | 1995-02-14 | Traditional | PDF ↗ |
| K933454 | DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM | L&H Airco | 1994-09-16 | Traditional | PDF ↗ |
| K932803 | CLESTRACLEAN(R) ROOM AIR PURIFIER | Clestra Cleanroom Technology, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K934914 | ICS 9400 ULTRAVIOLET AIR PURIFIER | Medair, Inc. | 1994-04-13 | Traditional | PDF ↗ |
| K920965 | STRAIGHT-LINES I.V. ORGANIZER | Taylor Bio-Medical, Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K884579 | UV AIR STERILIGHT | Allseasons Environmental Control, Inc. | 1988-12-12 | Traditional | PDF ↗ |
| K860132 | AIR CARE AIR SANITIZER | Cooper-Hewitt Electric Co. | 1987-01-13 | Traditional | PDF ↗ |
Product code FRA · Class II · General Hospital. Data: openFDA.