510(k) · Cleared
ClearedSyvekexcel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marine Polymer Technologies, Inc. · DXC Clamp, Vascular
Cleared on Mar 28, 2006 as substantially equivalent to K984177 (Marine Polymer Technologies, Inc., 1998) and 7 other predicates after a 123-day review. Its family tree reaches back 6 generations to 1995. 14 later devices descend from it.
- Decided
- Mar 28, 2006
- Review
- 123 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 6 generations to K953781 (1995). 25 ancestors in all, the oldest K896068 (1990). 14 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 5 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 4 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 3 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 2 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 1 generation backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- This deviceK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- Descendant · cites it directly · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · cites it directly · 5 of its ownK072890 Stasilon FREntegrion, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- Descendant · 3 generations on · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · cites it directly13descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 2 generations on5descendants
- K072890Stasilon FREntegrion, Inc. · 2007 · cites it directly5descendants
- K142363Nustat, Nustat XRBeeken Biomedical · 2015 · 2 generations on4descendants
- K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −5 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −4 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −3 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −2 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −1 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| 0 (this device) | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| +1 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| +2 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +1 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| +2 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
| +3 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K984177 | Modification to SkvekpatchSummary page 1…G. Regulatory Class: Class II (two) H. Product Code: DXC I. Predicate Devices: Marine Polymer Technologies, Inc.- SyvekPatch (K984 177) Advanced Vascular Dynamics- CompressAR SuperComfort Disc and Strong Arm SuperComfort System (K0406 15) Vascular Solutio… | 1998 |
| * | K040615 | Compressar Supercomfort Disc and Strongarm Supercomfort SystemSummary page 1…Devices: Marine Polymer Technologies, Inc.- SyvekPatch (K984 177) Advanced Vascular Dynamics- CompressAR SuperComfort Disc and Strong Arm SuperComfort System (K0406 15) Vascular Solutions, Inc. D-Stat Dry Hemostatic Bandage (K030836) Vascular Solutions, Inc. D-Stat Clamp Accessory (KO5O0146… | 2004 |
| * | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageSummary page 1…) Advanced Vascular Dynamics- CompressAR SuperComfort Disc and Strong Arm SuperComfort System (K0406 15) Vascular Solutions, Inc. D-Stat Dry Hemostatic Bandage (K030836) Vascular Solutions, Inc. D-Stat Clamp Accessory (KO5O0146) TZ Medical- EZ Hold (K973 132) RADI Medical Systems- Femosto… | 2003 |
| * | K050146 | Vascular Solutions D-Stat Clamp Accessory | 2005 |
| * | K973132 | EZ Hold 1 LBS., EZ Hold 2 LBSSummary page 1…stem (K0406 15) Vascular Solutions, Inc. D-Stat Dry Hemostatic Bandage (K030836) Vascular Solutions, Inc. D-Stat Clamp Accessory (KO5O0146) TZ Medical- EZ Hold (K973 132) RADI Medical Systems- Femostop Femoral Compression System (K024 107) RN4DS, Inc. Femoral Artery Vascular Pad (K964663)… | 1998 |
| * | K024107 | Femostop Femoral Compression SystemSummary page 1…e (K030836) Vascular Solutions, Inc. D-Stat Clamp Accessory (KO5O0146) TZ Medical- EZ Hold (K973 132) RADI Medical Systems- Femostop Femoral Compression System (K024 107) RN4DS, Inc. Femoral Artery Vascular Pad (K964663) Abbott Vascular Devices - Chito-SealTM (K02 1062)… | 2002 |
| * | K964663 | Favp: Femoral Artery Vascular Pad - Model Number PAD2EK-01, PAD2EK-2X, PAD5EK-R…Summary page 1…ccessory (KO5O0146) TZ Medical- EZ Hold (K973 132) RADI Medical Systems- Femostop Femoral Compression System (K024 107) RN4DS, Inc. Femoral Artery Vascular Pad (K964663) Abbott Vascular Devices - Chito-SealTM (K02 1062) 7… | 1997 |
| * | K021062 | Chito-SealSummary page 1…) RADI Medical Systems- Femostop Femoral Compression System (K024 107) RN4DS, Inc. Femoral Artery Vascular Pad (K964663) Abbott Vascular Devices - Chito-SealTM (K02 1062) 7… | 2002 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K061219 (Vascular Solutions, Inc., 2006) has gone furthest, with 13 descendants of its own.
- 9 other devices also cite its predicate K984177.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
Syvekexcel® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053300: Syvekexcel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053300
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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