Device class
Class II
Regulation 880.5045
Total clearances
9
2020-12-28 → 2025-11-14
Classification details
Medical specialty
General Hospital
Regulation number
880.5045
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Cerrozone, LLC |
2 |
0 |
2024-11-19 |
|
Beiang Air Tech , Ltd. |
1 |
0 |
2022-11-22 |
|
Winix, Inc. |
1 |
0 |
2022-09-14 |
|
Biomoneta Research Private Limited |
1 |
1 |
2025-11-14 |
|
Medify Air, LLC |
1 |
0 |
2023-09-18 |
|
Novaerus Us, Inc. |
1 |
0 |
2020-12-28 |
|
Suzhou Beiang Smart Technology Co., Ltd. |
1 |
0 |
2024-06-14 |
|
Ria Tech Co., Ltd. |
1 |
0 |
2023-05-01 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| E1601 |
HCPCS
|
— |
Medium
|
Medical air recirculation equipment; may be billed under equipment rental codes |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-11-14 |
K251872 |
Biomoneta Research Private Limited
|
Biomoneta Avata Rx |
| 2024-11-19 |
K242102 |
Cerrozone, LLC
|
CerroZone Mini |
| 2024-06-14 |
K240696 |
Suzhou Beiang Smart Technology Co., Ltd.
|
Airdog X8 Air Purifier (KJ800F-X8) |
| 2023-09-18 |
K223835 |
Medify Air, LLC
|
MA-40, MA-112 |
| 2023-05-01 |
K222416 |
Ria Tech Co., Ltd.
|
RIA Safeguard |
| 2022-11-22 |
K211507 |
Beiang Air Tech , Ltd.
|
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) |
| 2022-09-14 |
K220990 |
Winix, Inc.
|
Qorda QD1 |
| 2022-07-01 |
K220298 |
Cerrozone
|
CerroZone Mobile |
| 2020-12-28 |
K200321 |
Novaerus Us, Inc.
|
Novaerus NV1050 |