# K191089: Edwards Pressure Cable

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 13, 2019 after 50 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K941811 (1994). 178 ancestors in all.
No later device cites it as a predicate yet.
1 of 179 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable, Edwards Lifesciences, LLC (2018) Summary page 4.

## Indications for use
The Edwards Pressure Cable when used with an Edwards’ pressure monitoring sensor and connected to a compatible monitor, offers continuous assessment of hemodynamic parameters. The Edwards Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.

Source page: https://510kreport.com/device/K191089
Methodology: https://510kreport.com/methodology