510(k) · Cleared
ClearedWoven and Knitted Minicrimp Carotid Patch Fabrics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meadox Medicals, Div. Boston Scientific Corp. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Mar 11, 1991 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Mar 11, 1991
- Review
- 94 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK905496 Woven and Knitted Minicrimp Carotid Patch FabricsMeadox Medicals, Div. Boston Scientific Corp. · 1991
- Descendant · cites it directly · 12 of its ownK982810 Shelhigh NO-React VascupatchShelhigh, Inc. · 1998
- Descendant · 2 generations on · 11 of its ownK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K982810Shelhigh NO-React VascupatchShelhigh, Inc. · 1998 · cites it directly12descendants
- K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · 2 generations on11descendants
- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 3 generations on4descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 4 generations on3descendants
- K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905496 | Woven and Knitted Minicrimp Carotid Patch Fabrics | Meadox Medicals, Div. Boston Scientific Corp. | 1991 | — |
| +1 | K982810 | Shelhigh NO-React Vascupatch | Shelhigh, Inc. | 1998 | — |
| +2 | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | — |
| +3 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +4 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
| +5 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo… | Aziyo Biologics, Inc. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982810 | Shelhigh NO-React Vascupatch | 1998 | 12 |
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, K982810 (Shelhigh, Inc., 1998) has gone furthest, with 12 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 | — |
https://510kreport.com/device/K905496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905496: Woven and Knitted Minicrimp Carotid Patch Fabrics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905496
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026