# K821057: Flow Directed Thermal-Dilution Infusion

- Pathway: 510(k) (Traditional)
- Applicant: Oximetrix, Inc.
- Decided: May 18, 1982 after 32 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K061450: Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care Catheters (2006), 1 descendant of its own
- K091268: Hospira Latex-Free Critical Care and Advanced Sensor Catheters (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K821057
Methodology: https://510kreport.com/methodology