510(k) · Cleared
ClearedGore-Tes Expanded Ptfe Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Jan 12, 1983 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 12, 1983
- Review
- 216 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK821717 Gore-Tes Expanded Ptfe PatchW. L. Gore & Associates, Inc. · 1983
- Descendant · cites it directly · 3 of its ownK962342 Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996 · Recalled
- Descendant · 2 generations on · 1 of its ownK112683 Smi Cardiovascular PachSolimas Medical, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK122105 Smi Cardiovascular PatchSolinas Medical, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK101740 Albosure Polyester Vascular PatchLeMaitre Vascular, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K962342Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996 · cites it directly3descendants
- K112683Smi Cardiovascular PachSolimas Medical, Inc. · 2011 · 2 generations on1descendant
- K122105Smi Cardiovascular PatchSolinas Medical, Inc. · 2012 · 3 generations on0descendants
- K101740Albosure Polyester Vascular PatchLeMaitre Vascular, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821717 | Gore-Tes Expanded Ptfe Patch | W. L. Gore & Associates, Inc. | 1983 | — |
| +1 | K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | 2 |
| +2 | K112683 | Smi Cardiovascular Pach | Solimas Medical, Inc. | 2011 | — |
| +3 | K122105 | Smi Cardiovascular Patch | Solinas Medical, Inc. | 2012 | — |
| +2 | K101740 | Albosure Polyester Vascular Patch | LeMaitre Vascular, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch | 1996 | 3 |
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, K962342 (Meadox Medicals, Div. Boston Scientific Corp., 1996) has gone furthest, with 3 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/K821717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K821717: Gore-Tes Expanded Ptfe Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821717
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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