510(k) · Cleared
ClearedSmi Cardiovascular Pach
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solimas Medical, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Dec 14, 2011 as substantially equivalent to K984526 (W. L. Gore & Associates, Inc., 1999) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Dec 14, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K811841 (1981). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK112683 Smi Cardiovascular PachSolimas Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK122105 Smi Cardiovascular PatchSolinas Medical, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122105Smi Cardiovascular PatchSolinas Medical, Inc. · 2012 · cites it directly0descendants
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) | K112683 | Smi Cardiovascular Pach | Solimas Medical, Inc. | 2011 | — |
| +1 | K122105 | Smi Cardiovascular Patch | Solinas Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K984526 | Acuseal Cardiovascular PatchSummary page 1…edicate Devicest_ Manufacturer Device Name 510(k) Number W.L. Gore & Associates, Inc. ACUSEAL K984526 Cardiovascular Patch Meadox Medicals, Inc. Hemashield Finesse… | 1999 |
| * | K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchSummary page 1…ACUSEAL K984526 Cardiovascular Patch Meadox Medicals, Inc. Hemashield Finesse K962342 Ultra-thin Knitted Cardiovascular Patch… | 1996 |
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 1…astic Knit Pre-amendment Fabric Idevice Teleflex, Inc. Cottony Silky 11Polydeck K021019 Tevdek Desbription The SMI Cardiovascular Patch is designed for cardiovascular patching.… | 2002 |
| * | — | DeBakey Elastic Knit Fabric Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122105 | Smi Cardiovascular Patch | 2012 | 0 |
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 30 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K122105 (Solinas Medical, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K984526.
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. 2011, 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 Salinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112683: Smi Cardiovascular Pach.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112683
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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