# K902628: Interflo Medical Model Interflo/1 Cardiac Output

- Pathway: 510(k) (Traditional)
- Applicant: Biometric Research Institute, Inc.
- Decided: Feb 25, 1991 after 257 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 21, 2006 · Not classified · Z-1310-06: Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user

Source page: https://510kreport.com/device/K902628
Methodology: https://510kreport.com/methodology