510(k) · Cleared
ClearedFibresolve (with PCCP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imvaria, Inc. · QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Cleared on Nov 7, 2025 as substantially equivalent to DEN220040 (Imvaria, Inc., 2024) after a 130-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Nov 7, 2025
- Review
- 130 days
- Class
- Class II
- Product code
- QWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220040 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220040 FibresolveImvaria, Inc. · 2024
- This deviceK252041 Fibresolve (with PCCP)Imvaria, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220040 | Fibresolve | Imvaria, Inc. | 2024 | — |
| 0 (this device) | K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | 2025 | — |
Sources: FDA 510(k) 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 QWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QWO device
- #1 K241891 ScreenDxscore 8.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN220040 | FibresolveSummary page 6…ION Fibresolve (with PCCP) is substantially equivalent to the following predicate: 510(k) Number Device/Manufacturer Predicate/Reference DEN220040 Fibresolve / Imvaria, Inc Predicate DEVICE DESCRIPTION Fibresolve is a software system dev… | 2024 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN220040.
How does its category compare?
All QWO devicesQWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWO
Too few QWO 510(k)s in any year since 2007 to give a median.
Recalls per year · QWO
No recall names QWO since 2007.
Adverse event reports per year · QWO
No MAUDE report names QWO 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 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). The device supplements the standard-of-care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition, in order to provide adjunctive information as part of a…
Read the full statement (177 words)
Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to
provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). The device supplements the
standard-of-care workflow by providing a qualitative, diagnostic classification output of imaging findings based on
machine learning pattern recognition, in order to provide adjunctive information as part of a referral pathway to an
appropriate Multidisciplinary Discussion (MDD) or as part of an MDD. Specifically, the tool is used to serve as an adjunct
in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing. The results of Fibresolve are intended to
be used only by clinicians qualified in the care of lung disease, specifically in caring for patients with ILD, in conjunction
with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.
The input to Fibresolve must include a DICOM-compliant lung CT scan. Clinical case eligibility includes the following
criteria:
● Age > 22 years old.
● Pulmonary symptoms suggestive of possible ILD including IPF.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252041: Fibresolve (with PCCP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252041
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026