De Novo · Granted
GrantedPCWP Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiosense, Inc. · SIF Software Device System For Estimation Of Cardiac Pressures
Granted on May 22, 2026 as a new device type through De Novo after a 186-day review.
- Decided
- May 22, 2026
- Review
- 186 days
- Class
- Class II
- Product code
- SIF
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SIF devicesSIF Software Device System For Estimation Of Cardiac Pressures: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIF
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIF
Too few SIF 510(k)s in any year since 2007 to give a median.
Recalls per year · SIF
No recall names SIF since 2007.
Adverse event reports per year · SIF
No MAUDE report names SIF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (131 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250057 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250057: PCWP Analysis Software.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250057
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026