510(k) · Cleared
ClearedPeriBeam® Pericardial Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tamabio · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Apr 18, 2025 as substantially equivalent to K012098 (W. L. Gore & Associates, Inc., 2001) after a 393-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 18, 2025
- Review
- 393 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012098 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK012098 Preclude Pericardial MembraneW. L. Gore & Associates, Inc. · 2001
- This deviceK240775 PeriBeam® Pericardial MembraneTamabio · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012098 | Preclude Pericardial Membrane | W. L. Gore & Associates, Inc. | 2001 | — |
| 0 (this device) | K240775 | PeriBeam® Pericardial Membrane | Tamabio | 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 DXZ? 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 DXZ device
- #1 K200955 Vascutek Gelseal Patch, Vascutek Gelsoft…score -0.1 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K012098 | Preclude Pericardial MembraneSummary page 5…Polypropylene Regulation # 870.3470 Product Code(s) DXZ Predicate Name PRECLUDE® Preicardial Membrane Predicate Number K012098 Predicate Product Code DXZ Device Description PeriBeam® is an ion-irradiated, expanded polytetrafluoroethylene… | 2001 |
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 K012098.
How does its category compare?
All DXZ devicesDXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DXZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXZ
106in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXZ
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DXZ
119in 2025
MAUDE reports naming product code DXZ, 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 | 1 | — | 0 | 50 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 109 |
| 2010 | 3 | 91 | 2 | 81 |
| 2011 | 2 | — | 2 | 47 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 1 | — | 2 | 69 |
| 2014 | 3 | 106 | 0 | 93 |
| 2015 | 2 | — | 0 | 171 |
| 2016 | 2 | — | 0 | 66 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 1 | 44 |
| 2019 | 0 | — | 0 | 55 |
| 2020 | 1 | — | 1 | 121 |
| 2021 | 0 | — | 0 | 80 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 2 | 40 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 1 | — | 2 (2) | 119 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.
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/K240775 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240775: PeriBeam® Pericardial Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240775
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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