GEM-6 with Components
by Diamond Electro-Tech, Inc. 510(k)
Active
510(k) K854357
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854357 | Date8 Jan 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The GEM-6 with Components is an Online Blood-Gas Monitor designed for use during cardiopulmonary bypass procedures. It continuously measures arterial blood gases, including oxygen (PaO₂), carbon dioxide (PaCO₂), and pH levels, to ensure precise physiological monitoring and support during cardiac surgery. The device integrates with bypass circuits to provide real-time feedback, enabling clinicians to maintain optimal hemodynamic stability and oxygenation. Its role is critical in high-risk cardiac interventions where rapid adjustments to ventilation or perfusion are necessary.
This device is supplied as a reusable system, intended for use in sterile operating room environments during cardiothoracic procedures. It requires calibration and maintenance as specified by the manufacturer, with components designed for compatibility with standard cardiopulmonary bypass equipment. The GEM-6 with Components is classified under FDA 510(k) clearance (K854357) and adheres to regulatory standards for Class II medical devices (DRY product code). No specific MRI safety labeling is indicated, and its use is restricted to controlled clinical settings where trained personnel can operate and monitor the system.
Questions
AI-generated answers, 1 Oct 2026
What is the GEM-6 with Components used for in cardiac surgery?
The GEM-6 with Components is designed specifically for use during cardiopulmonary bypass procedures in cardiac surgery. It continuously measures arterial blood gases—including oxygen (PaO₂), carbon dioxide (PaCO₂), and pH levels—to provide real-time physiological feedback. This allows clinicians to make immediate adjustments to ventilation or perfusion, maintaining optimal hemodynamic stability and oxygenation in high-risk interventions.
Is the GEM-6 with Components a single-use or reusable device?
The GEM-6 with Components is supplied as a reusable system. It is intended for use in sterile operating room environments during cardiothoracic procedures and requires calibration and maintenance as outlined by the manufacturer. Its reusable components are designed for compatibility with standard cardiopulmonary bypass equipment, ensuring long-term reliability in clinical settings.
What regulatory clearance does the GEM-6 with Components hold?
The GEM-6 with Components holds FDA 510(k) clearance under the reference number K854357. It is classified as a Class II medical device under the product code DRY, adhering to regulatory standards for online blood-gas monitoring during cardiopulmonary bypass procedures. The device was reviewed by the Cardiovascular (CV) Advisory Committee and is intended for use in controlled clinical settings.
Can the GEM-6 with Components be used with MRI equipment?
The GEM-6 with Components does not have specific MRI safety labeling indicated. Its use is restricted to non-MRI environments, particularly in operating rooms where cardiothoracic procedures are performed. Clinicians should ensure the device is operated in settings where MRI compatibility is not required, as there is no documented approval for MRI-safe use.
What maintenance or calibration is required for the GEM-6 with Components?
As a reusable system, the GEM-6 with Components requires regular calibration and maintenance to ensure accurate and reliable performance. The manufacturer provides specific guidelines for these procedures, which must be followed to maintain compliance with regulatory standards and clinical safety. Proper upkeep is essential for continuous monitoring of arterial blood gases during cardiopulmonary bypass.