510(k) · Cleared
ClearedPhotoFix Decellularized Bovine Pericardium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryolife, Inc. · PSQ Intracardiac Patch Or Pledget, Biologically Derived
Cleared on Feb 14, 2019 as substantially equivalent to K172085 (Cryolife, Inc., 2017) after a 50-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Feb 14, 2019
- Review
- 50 days
- Class
- Class II
- Product code
- PSQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K172085 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backK172085 PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
- This deviceK183635 PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K172085 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017 | — |
| 0 (this device) | K183635 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2019 | — |
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 PSQ? 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 PSQ device
- #1 K210331 CardiaMend Pericardial and Epicardial…score 4.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K172085 | PhotoFix Decellularized Bovine PericardiumSummary page 4…Code PhotoFix® Decellularized Bovine CryoLife, Inc. K172085 PSQ Pericardium Device Description The PhotoFix® Decellularized Bovine Pericardium (“PhotoFix”) i… | 2017 |
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.
How does its category compare?
All PSQ devicesPSQ Intracardiac Patch Or Pledget, Biologically Derived: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PSQ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PSQ
73in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSQ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSQ
1in 2025
MAUDE reports naming product code PSQ, not matched to any one device; reports are not rates.
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 | 3 | 73 | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 2 | 4 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PhotoFix is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).
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/K183635 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183635: PhotoFix Decellularized Bovine Pericardium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183635
Report an extraction error
Are you the manufacturer?
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