Purgo
FDA 510(k) clearance K223328 · decided 2022-11-30
Clearance details
- K-number
- K223328
- Device name
- Purgo
- Applicant
- Aeroclean Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-10-31
- Decision date
- 2022-11-30
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FRA
- Device class
- 2
- Regulation number
- 880.6500
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Aeroclean Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Zener® (model ZEN-001-B1) (K252128) | Uvx, Inc. | 2025-09-15 |
| ViroZap Indoor Air Purifier, In Duct Model 1008 (K241140) | Applied Photonix, LLC | 2024-08-01 |
| 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 Corporation | 2024-02-16 |
| Synexis Sphere Rx (K221540) | Synexis, LLC | 2023-06-14 |
| RGS; RGS Mini (K222702) | Genesis Air, Inc. | 2023-06-02 |
| Purgo (K213753) | Aeroclean Technologies, LLC | 2022-06-01 |
| Aura Storm (K212644) | Invictus Lighting | 2022-05-26 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.