Device class
Class II
Regulation 868.1900
Total clearances
6
2021-03-11 → 2026-06-02
Definition
What is Abnormal Breath Sound Device
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Classification details
Medical specialty
Anesthesiology
Regulation number
868.1900
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Tyto Care , Ltd.
|
5 |
1 |
2026-06-02 |
|
Respiri Limited |
1 |
0 |
2021-03-11 |
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 |
| 94060 |
CPT
|
— |
Medium
|
Spirometry testing for abnormal breath sound assessment, context-dependent |
| 94070 |
CPT
|
— |
Medium
|
Bronchospasm evaluation relevant to wheeze/rhonchi detection |
Pulse
Most recent 510(k) clearances