Computer, Cardiac Output, Model KM275
510(k) K770675
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770675 | Date26 Apr 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1435
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Computer, Cardiac Output, Model KM275 is a pre-programmed, single-function diagnostic device designed to measure and compute cardiac output. Cardiac output is a critical hemodynamic parameter reflecting the volume of blood the heart pumps per minute, essential for assessing cardiac function and guiding clinical interventions. This device is classified as a Class II medical device under FDA regulations and falls within the cardiovascular specialty category.
The Model KM275 is intended for use in clinical settings such as hospitals and cardiac care units, where precise hemodynamic monitoring is required. Supplied as a reusable device, it operates under sterile conditions when used in direct patient care. The device is not MRI-safe and must be used in environments where magnetic resonance imaging is not performed. Authorized under FDA 510(k) clearance (K770675) and regulated under regulation number 870.1435, it adheres to traditional clearance pathways. Storage and handling follow standard medical device protocols to maintain functionality and sterility.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the KM275 cardiac output computer?
The KM275 is a pre-programmed diagnostic device designed to measure and calculate cardiac output, which is the volume of blood the heart pumps through the circulatory system per minute. This measurement is critical for evaluating cardiac function and guiding clinical interventions, particularly in settings such as hospitals and cardiac care units where accurate hemodynamic monitoring is essential.
Is the KM275 a single-use or reusable device?
The KM275 is a reusable device. While it is intended for use in direct patient care, it must be handled under sterile conditions to ensure patient safety and device integrity. Standard medical device protocols for storage and handling apply to maintain its functionality and sterility over repeated uses.
Can the KM275 be used in environments where MRI is performed?
No, the KM275 is not MRI-safe. It should only be used in clinical environments where magnetic resonance imaging is not conducted, as exposure to MRI fields could potentially affect its performance or pose risks to the device.
What regulatory pathway does the KM275 follow?
The KM275 is authorized under the FDA 510(k) clearance pathway, specifically with clearance number K770675. It is classified as a Class II medical device under FDA regulations and falls within the cardiovascular specialty category. The device adheres to traditional clearance pathways and is regulated under regulation number 870.1435.
How should the KM275 be stored to maintain its functionality?
The KM275 should be stored and handled according to standard medical device protocols. These protocols typically include maintaining a clean, dry environment, protecting the device from physical damage, and ensuring it remains free from contamination to preserve its sterility and operational integrity for reuse.