510(k) · Cleared
ClearedShelhigh NO-React Vascupatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shelhigh, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Oct 28, 1998 as substantially equivalent to K905496 (Meadox Medicals, Div. Boston Scientific Corp., 1991) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1997. 12 later devices descend from it.
- Decided
- Oct 28, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964467 (1997). 3 ancestors in all, the oldest K905496 (1991). 12 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK964467 Shelhigh Pericardial PatchShelhigh, Inc. · 1997
- 1 generation backK974914 Shelhigh NO-React Pericardial PatchesShelhigh, Inc. · 1998
- This deviceK982810 Shelhigh NO-React VascupatchShelhigh, Inc. · 1998
- Descendant · cites it directly · 11 of its ownK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK152127 CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · cites it directly11descendants
- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 2 generations on4descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 3 generations on3descendants
- K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 4 generations on2descendants
- K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964467 | Shelhigh Pericardial Patch | Shelhigh, Inc. | 1997 | — |
| −1 | K974914 | Shelhigh NO-React Pericardial Patches | Shelhigh, Inc. | 1998 | — |
| 0 (this device) | K982810 | Shelhigh NO-React Vascupatch | Shelhigh, Inc. | 1998 | — |
| +1 | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | — |
| +2 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +3 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
| +4 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo… | Aziyo Biologics, Inc. | 2018 | 1 |
| +2 | K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (2)
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 |
|---|---|---|---|
| * | K905496 | Woven and Knitted Minicrimp Carotid Patch FabricsSummary page 1…planted material. V. Substantial Equivalence The Shelhigh No-React® VascuPatch™ is equivalent to the Knitted MiniCrimp Vascupatch manufactured by Meadox Medical, Inc. #K905496 and identical to the Shelhigh No-React® pericardial patch K974914 currently manufactured by Shelhigh Inc. VIi. Comparison with P… | 1991 |
| * | K974914 | Shelhigh NO-React Pericardial PatchesSummary page 1…ct® VascuPatch™ is equivalent to the Knitted MiniCrimp Vascupatch manufactured by Meadox Medical, Inc. #K905496 and identical to the Shelhigh No-React® pericardial patch K974914 currently manufactured by Shelhigh Inc. VIi. Comparison with Predicate Device The Shelhigh No-React® VascuPatch™ like the Shel… | 1998 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063349 | Cormatrix Patch for Cardiac Tissue Repair | 2007 | 11 |
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?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063349 (Cormatrix Cardiovascular, Inc., 2007) has gone furthest, with 11 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?
For repair of carotid endarterectomy and vascular patch grafting.
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/K982810 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982810: Shelhigh NO-React Vascupatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982810
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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