510(k) · Cleared
ClearedAlbosure Polyester Vascular Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LeMaitre Vascular, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Sep 20, 2010 as substantially equivalent to K962342 (Meadox Medicals, Div. Boston Scientific Corp., 1996) after a 91-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Sep 20, 2010
- Review
- 91 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K811841 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK811841 Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc. · 1981
- 1 generation backK962342 Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996 · Recalled
- This deviceK101740 Albosure Polyester Vascular PatchLeMaitre Vascular, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811841 | Gore-Tex Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1981 | — |
| −1 | K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | 2 |
| 0 (this device) | K101740 | Albosure Polyester Vascular Patch | LeMaitre Vascular, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchSummary page 1…polyethylene terephthalate, or polytetrafluoroethylene Predicate Device: Hemashield Finesse Knitted Cardiovascular Patch (K962342) Device Description: AlboSure Polyester Vascular Patch is a knitted polyester - fabric, impregnat… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K962342.
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. 2010, this device’s year, is highlighted.
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?
The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101740 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101740: Albosure Polyester Vascular Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101740
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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