510(k) · Cleared
ClearedSulzer Carbomedics Cardiofix Pericardium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Carbomedics, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Dec 29, 1999 after an 89-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Dec 29, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK993288 Sulzer Carbomedics Cardiofix PericardiumSulzer Carbomedics, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK031785 Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK162506 PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK090637 Cardio-WrapMast Biosurgery USA, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK081438 Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health · 2008
Most influential descendants
Showing 4 of 4 · See all- K031785Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc. · 2003 · cites it directly1descendant
- K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017 · cites it directly0descendants
- K090637Cardio-WrapMast Biosurgery USA, Inc. · 2010 · 2 generations on0descendants
- K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993288 | Sulzer Carbomedics Cardiofix Pericardium | Sulzer Carbomedics, Inc. | 1999 | — |
| +1 | K031785 | Macropore Cardio-Wrap (TS) | Macropore Biosurgery, Inc. | 2003 | — |
| +1 | K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017 | — |
| +2 | K090637 | Cardio-Wrap | Mast Biosurgery USA, Inc. | 2010 | — |
| +1 | K081438 | Matracell Decellularized Pulmonary Artery Patch Allograft | Lifenet Health | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
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 K240775 PeriBeam® Pericardial Membranescore 9.2 · 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 |
|---|---|---|---|
| * | — | Bio-Vascular Peri-Guard Pericardium Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K031785 (Macropore Biosurgery, Inc., 2003) has gone furthest, with 1 descendant of its own.
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.
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?
Sulzer Carbomedics CardioFix™ Pericardium is indicated for the following uses:
Intracardiac Repair
» Ventricular repair using a reinforced patch technique (i.e., minimum of double thickness).
» Atrial Repair.
Great vessel repair and suture line buttressing using a reinforced patch technique (i.e., minimum of double thickness) for applications exposed to peak systolic pressure.
Pericardial Closure.
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/K993288 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993288: Sulzer Carbomedics Cardiofix Pericardium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993288
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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