Compact Monitor SMK 210, 211, 230, 231, 240
510(k) K903917
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903917 | Date18 Jan 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3535
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Compact Monitor SMK 210, 211, 230, 231, 240 is a cardiovascular patient monitoring system designed for intra-aortic balloon pump control. It provides real-time monitoring and management of intra-aortic balloon-assisted circulatory support, enabling precise timing and synchronization of balloon inflation and deflation to optimize cardiac output and myocardial perfusion in critical care settings.
This device is intended for use in clinical environments such as operating rooms, intensive care units, and cardiac catheterization labs. Supplied as a reusable medical system, it requires proper sterilization and maintenance per manufacturer guidelines. The device is classified as Class II under FDA regulations and holds a Traditional 510(k) clearance (K903917) for cardiovascular applications. Compliance with regulatory standards ensures safe integration into existing intra-aortic balloon pump systems, adhering to FDA’s 870.3535 classification for balloon control systems.
Other devices from Ppg Hellige B.V.
Questions
AI-generated answers, 1 Oct 2026
What is the Compact Monitor SMK 210/211/230/231/240 used for?
This device is designed specifically for intra-aortic balloon pump (IABP) control in cardiovascular patients. It provides real-time monitoring and synchronization of balloon inflation/deflation to improve cardiac output and myocardial perfusion in high-risk settings like operating rooms, intensive care units, and cardiac catheterization labs. The precise timing ensures optimal support during critical interventions.
Is the Compact Monitor SMK 240 reusable or single-use?
The Compact Monitor SMK 240 is a reusable medical system. It requires proper sterilization and maintenance as outlined in the manufacturer’s guidelines to ensure safe and reliable performance over repeated use. Regular upkeep is essential for maintaining accuracy and compliance with clinical standards.
What models are included in the Compact Monitor SMK series?
The series includes the SMK 210, SMK 211, SMK 230, SMK 231, and SMK 240. These models are designed for intra-aortic balloon pump control, with variations likely tailored to specific clinical or system integration needs. The SMK 240 is the most recent or distinct model in this lineup.
How should the Compact Monitor SMK 240 be stored?
Storage conditions for the Compact Monitor SMK 240 should follow the manufacturer’s instructions to preserve functionality and sterility. As a reusable device, it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging and maintenance protocols should be adhered to between uses to prevent contamination or damage.
What regulatory clearance does the Compact Monitor SMK series hold?
The Compact Monitor SMK series holds a Traditional 510(k) clearance (K903917) from the FDA under the classification for cardiovascular applications. This clearance confirms that the device meets FDA standards for safety and effectiveness as a balloon control system for intra-aortic support, ensuring compliance with regulatory requirements for use in clinical settings.