Device class
—
Regulation —
Total clearances
3
2023-11-03 → 2025-10-15
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Zoll Circulation, Inc.
|
2 |
1 |
2025-10-15 |
|
Global Healthcare SG Sdn. Bhd |
1 |
0 |
2025-03-18 |
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 |
| 93000 |
CPT
|
— |
Medium
|
Electrocardiogram CPT; temperature/cardiac monitoring overlap in hypothermia treatment |
| E1625 |
HCPCS
|
Water softening system, for hemodialysis ✓ CMS-verified description |
Medium
|
Warming/cooling blanket or pad rental device |
| 99213 |
CPT
|
— |
Low
|
Office visit code if device monitoring bundled into E/M |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-10-15 |
K250979 |
Zoll Circulation, Inc.
|
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) |
| 2025-03-18 |
K240933 |
Global Healthcare SG Sdn. Bhd
|
CarbonCool® System |
| 2023-11-03 |
K231182 |
Zoll Circulation, Inc.
|
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System |