510(k) · Decided
DecidedTissue Patch, Tissue Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Nov 4, 1992 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 411 devices in its family, counting itself, have a Class I recall. 410 later devices descend from it.
- Decided
- Nov 4, 1992
- Review
- 196 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 0
410 later devices descend from it, 7 citing it directly. 2 of the 411 devices in this family, counting this one, have a Class I recall.
- This deviceK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- Descendant · cites it directly · 409 of its ownK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- Descendant · cites it directly · 336 of its ownK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 284 of its ownK980431 SurgisisCook Biotech, Inc. · 1998
- Descendant · 3 generations on · 204 of its ownK992159 Surgisis SlingCook Biotech, Inc. · 1999
- Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
Showing 5 of 410 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 410 · See all- K961810Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996 · cites it directly409descendants
- K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc. · 1998 · cites it directly336descendants
- K980431SurgisisCook Biotech, Inc. · 1998 · 2 generations on284descendants
- K992159Surgisis SlingCook Biotech, Inc. · 1999 · 3 generations on204descendants
- K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| +1 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| +1 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| +2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| +3 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| +2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 13 | 0 |
| 2006 | 13 | 0 |
| 2007 | 15 | 0 |
| 2008 | 22 | 0 |
| 2009 | 16 | 0 |
| 2010 | 14 | 0 |
| 2011 | 15 | 1 |
| 2012 | 17 | 0 |
| 2013 | 19 | 0 |
| 2014 | 24 | 1 |
| 2015 | 14 | 0 |
| 2016 | 25 | 0 |
| 2017 | 30 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 16 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 15 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (410)
See all 4107 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961810 | Supple Peri-Guard Pericardium | 1996 | 409 |
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | 1998 | 336 |
| K983602 | CV Peri-Guard and Vascu-Guard | 1998 | 31 |
| K040835 | Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 | 2004 | 17 |
| K033985 | Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 | 2004 | 1 |
| K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap | 1997 | 1 |
| K122306 | Synovis Collagen Matrix (TBD) | 2013 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K961810 (Bio-Vascular, Inc., 1996) has gone furthest, with 409 descendants 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?
Supple Peri-Guard is intended for use during cardiac surgical procedures as a patch for closure of the patient's pericardium. The patch may be tailored during surgery to meet the surgeon's needs.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K921895 · printed Nov 5, 2026
Cite this page
510(k) Report. “K921895: Tissue Patch, Tissue Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921895
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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