Device class
—
Regulation —
Total clearances
6
2021-01-06 → 2026-05-20
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Usa Therm, Inc. |
2 |
0 |
2023-09-14 |
|
Thermidas Americas, Inc. |
1 |
0 |
2021-01-06 |
|
Niramai Health Analytix Private Limited |
1 |
0 |
2022-03-10 |
|
Medicore Co., Ltd. |
1 |
0 |
2021-09-13 |
|
Neko Health AB |
1 |
1 |
2026-05-20 |
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 |
| 76999 |
CPT
|
— |
Low
|
Telethermography is rarely billed; 76999 is unlisted diagnostic ultrasound/imaging fallback |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-05-20 |
K253911 |
Neko Health AB
|
Derma-2 |
| 2023-09-14 |
K232462 |
Usa Therm, Inc.
|
ThermPix Thermovisual Camera |
| 2022-04-12 |
K213650 |
Usa Therm, Inc.
|
ThermPix Thermovisual Camera |
| 2022-03-10 |
K212965 |
Niramai Health Analytix Private Limited
|
Smile-100 System |
| 2021-09-13 |
K212412 |
Medicore Co., Ltd.
|
IRIS-XP |
| 2021-01-06 |
K200999 |
Thermidas Americas, Inc.
|
Thermidas IR System (ThIR-A615) |