Device class
Class II
Regulation 870.5900
Total clearances
3
2023-11-03 → 2025-10-15
Definition
What is Hyperthermia Monitor
Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).
Classification details
Medical specialty
Cardiovascular
Regulation number
870.5900
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 |