510(k) · Cleared
ClearedBaxter Eptfe Externally Supported Vascular Grafts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Edwards · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Jan 5, 1995 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jan 5, 1995
- Review
- 94 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK944858 Baxter Eptfe Externally Supported Vascular GraftsBaxter Edwards · 1995
- Descendant · cites it directly · 9 of its ownK032900 Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally…Edwards Lifesciences, LLC · 2003
- Descendant · 2 generations on · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK091491 Hero Vascular Access DeviceHemosphere, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK120006 Hero GraftHemosphere, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK121532 Hero GraftHemosphere, Inc. · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K032900Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular…Edwards Lifesciences, LLC · 2003 · cites it directly9descendants
- K071778Hero Vascular Access DeviceGraftcath, Inc. · 2008 · 2 generations on7descendants
- K091491Hero Vascular Access DeviceHemosphere, Inc. · 2009 · 3 generations on6descendants
- K120006Hero GraftHemosphere, Inc. · 2012 · 3 generations on5descendants
- K121532Hero GraftHemosphere, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944858 | Baxter Eptfe Externally Supported Vascular Grafts | Baxter Edwards | 1995 | — |
| +1 | K032900 | Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported… | Edwards Lifesciences, LLC | 2003 | — |
| +2 | K071778 | Hero Vascular Access Device | Graftcath, Inc. | 2008 | — |
| +3 | K091491 | Hero Vascular Access Device | Hemosphere, Inc. | 2009 | — |
| +3 | K120006 | Hero Graft | Hemosphere, Inc. | 2012 | — |
| +3 | K121532 | Hero Graft | Hemosphere, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 DSY? 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 DSY device
- #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (10)
2 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?
- Of its descendants, K032900 (Edwards Lifesciences, LLC, 2003) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DSY devicesDSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSY
160in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSY
151in 2025
MAUDE reports naming product code DSY, 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 | 120 |
| 2008 | 1 | — | 0 | 164 |
| 2009 | 5 | 73 | 2 | 193 |
| 2010 | 4 | 55 | 5 | 187 |
| 2011 | 1 | — | 0 | 165 |
| 2012 | 4 | 30 | 0 | 177 |
| 2013 | 5 | 69 | 1 | 207 |
| 2014 | 2 | — | 0 | 352 |
| 2015 | 1 | — | 0 | 460 |
| 2016 | 1 | — | 2 | 217 |
| 2017 | 3 | 269 | 0 | 193 |
| 2018 | 1 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 232 |
| 2020 | 1 | — | 0 | 169 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 155 |
| 2023 | 2 | — | 0 | 149 |
| 2024 | 5 | 160 | 0 | 153 |
| 2025 | 2 | — | 1 | 151 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K944858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944858: Baxter Eptfe Externally Supported Vascular Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944858
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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