510(k) · Cleared
ClearedLifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Dec 4, 2003 as substantially equivalent to K933590 (Baxter Healthcare Corp, 1994) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1994. 9 later devices descend from it.
- Decided
- Dec 4, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K933590 (1994). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933590 Baxter Reinforced Expanded Ptfe Vascular GraftBaxter Healthcare Corp · 1994
- This deviceK032900 Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally…Edwards Lifesciences, LLC · 2003
- Descendant · cites it directly · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK091491 Hero Vascular Access DeviceHemosphere, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK120006 Hero GraftHemosphere, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK121532 Hero GraftHemosphere, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK124039 Hero GraftHemoshpere, Inc., A Cryolife Company · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K071778Hero Vascular Access DeviceGraftcath, Inc. · 2008 · cites it directly7descendants
- K091491Hero Vascular Access DeviceHemosphere, Inc. · 2009 · 2 generations on6descendants
- K120006Hero GraftHemosphere, Inc. · 2012 · 2 generations on5descendants
- K121532Hero GraftHemosphere, Inc. · 2012 · 2 generations on4descendants
- K124039Hero GraftHemoshpere, Inc., A Cryolife Company · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933590 | Baxter Reinforced Expanded Ptfe Vascular Graft | Baxter Healthcare Corp | 1994 | — |
| 0 (this device) | K032900 | Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported… | Edwards Lifesciences, LLC | 2003 | — |
| +1 | K071778 | Hero Vascular Access Device | Graftcath, Inc. | 2008 | — |
| +2 | K091491 | Hero Vascular Access Device | Hemosphere, Inc. | 2009 | — |
| +2 | K120006 | Hero Graft | Hemosphere, Inc. | 2012 | — |
| +2 | K121532 | Hero Graft | Hemosphere, Inc. | 2012 | — |
| +2 | K124039 | Hero Graft | Hemoshpere, Inc., A Cryolife Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (3)
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 |
|---|---|---|---|
| * | K933590 | Baxter Reinforced Expanded Ptfe Vascular GraftSummary page 2…Material Change ]LL 4. Predicate Device Identification: Baxter Reinforced Expanded PTFE Vascular Graft (K933590) Baxter Reinforced Expanded PTFE Stepped Vascular Graft (K944844) Baxter Reinforced Expanded PTIFE Exte… | 1994 |
| * | K944844 | Baxter Reinforced Expanded Ptfe Stepped Vascular GraftSummary page 2…edicate Device Identification: Baxter Reinforced Expanded PTFE Vascular Graft (K933590) Baxter Reinforced Expanded PTFE Stepped Vascular Graft (K944844) Baxter Reinforced Expanded PTIFE Externally Supported Vascular Grafts (K944858) 5. Device De… | 1995 |
| * | K944858 | Baxter Eptfe Externally Supported Vascular GraftsSummary page 2…Baxter Reinforced Expanded PTFE Stepped Vascular Graft (K944844) Baxter Reinforced Expanded PTIFE Externally Supported Vascular Grafts (K944858) 5. Device Description: The subject devices are vascular grafts consisting of a base tube of… | 1995 |
What descends from it? (9)
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?
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 | — |
What is it indicated for?
The Edwards Lifespan ePTFE Vascular Grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032900: Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032900
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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