Device class
Class II
Regulation 862.3080
Total clearances
5
2021-12-17 → 2025-11-26
Classification details
Medical specialty
Clinical Toxicology
Regulation number
862.3080
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Bosch Healthcare Solutions GmbH |
2 |
1 |
2025-09-11 |
|
Caire Diagnostics, Inc.
|
1 |
0 |
2023-06-07 |
|
Bedfont Scientific, Ltd. |
1 |
0 |
2021-12-17 |
|
Mgc Diagnostics Corporation |
1 |
1 |
2025-11-26 |
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 |
| 95012 |
CPT
|
— |
Medium
|
Allergy/immune function testing; breath analysis testing may use this or unlisted code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-11-26 |
K251674 |
Mgc Diagnostics Corporation
|
Fenom Flo FeNO Monitoring System |
| 2025-09-11 |
K243926 |
Bosch Healthcare Solutions GmbH
|
Vivatmo pro-S |
| 2024-02-22 |
K233775 |
Bosch Healthcare Solutions GmbH
|
Vivatmo pro |
| 2023-06-07 |
K213611 |
Caire Diagnostics, Inc.
|
Fenom Pro |
| 2021-12-17 |
K203695 |
Bedfont Scientific, Ltd.
|
NObreath® |