# DEN250057: PCWP Analysis Software

- Pathway: De Novo (Direct)
- Applicant: Cardiosense, Inc.
- Decided: May 22, 2026 after 186 days
- Product code: SIF (Software Device System For Estimation Of Cardiac Pressures)
- Device class: 2
- Regulation: 21 CFR 870.1150
- Recalls of this device: none
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
PCWP Analysis Software is intended to noninvasively estimate pulmonary capillary wedge pressure (PCWP) and identify patients with a PCWP above or below 18mmHg, for patients diagnosed with heart failure with reduced ejection fraction (HFrEF) and New York Heart Association (NYHA) Functional Class II, III, IV symptoms. The hemodynamic data will be used by qualified healthcare professionals in conjunction with other standard of care parameters to evaluate heart failure patients. The results of PCWP Analysis Software are intended to be used under the supervision of a qualified healthcare professional in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the qualified healthcare professional's judgment. Patient management decisions should not be made solely on the results of the PCWP Analysis Software. The device is only for prescription use.

Source page: https://510kreport.com/device/DEN250057
Methodology: https://510kreport.com/methodology