Identifiers
- 510(k) Number
- K070654 FDA 510(k)
- FDA Product Code
- LGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hyperthermia Pump is a thermal infusion fluid warmer used in therapeutic procedures to raise the temperature of the thoracic or intraperitoneal cavity. It functions by continuously lavaging the cavity with a warmed sterile solution that is pumped, withdrawn, reheated, and recirculated.
This device is regulated under FDA 510K clearance. It features an electromagnetic induction warmer and a touchscreen interface for temperature control.
Frequently asked questions
What is the primary function of the Hyperthermia Pump?
The device is a thermal infusion fluid warmer designed for use in therapeutic procedures. It functions by continuously lavaging the thoracic or intraperitoneal cavity with a warmed sterile solution that is pumped, withdrawn, reheated, and recirculated to maintain the desired temperature.
How does the device control the temperature of the solution?
The Hyperthermia Pump utilizes an electromagnetic induction warmer to heat the fluid. Clinicians manage the temperature settings through an integrated touchscreen interface located on the device.
What is the regulatory status of this device?
The Hyperthermia Pump is regulated under FDA 510K clearance. It was determined to be substantially equivalent to existing devices under the K070654 submission.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hyperthermia Treatment Pump - HIPEC Intraperitoneal Chemotherapy Device ..., Belmont Medical - Fluid Warming & Temperature Regulation Devices, Belmont Medical Technologies HYPERTHERMIA PUMP Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070654 | Class II | Active |
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Manufacturer
- Manufacturer
- Belmont Instrument Corp.
Sources (1)
- FDA 510(k) K070654 24 fields · synced Sep 25, 2026