510(k) · Decided
DecidedBaxter Reinforced Expanded Ptfe Stepped Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Cleared on Mar 31, 1995 after a 182-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
- Mar 31, 1995
- Review
- 182 days
- Class
- Class II
- Product code
- DYF
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK944844 Baxter Reinforced Expanded Ptfe Stepped Vascular GraftBaxter Healthcare Corp · 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) | K944844 | Baxter Reinforced Expanded Ptfe Stepped Vascular Graft | Baxter Healthcare Corp | 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 DYF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 DYF devicesDYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYF
FDA has decided no DYF device since 2007.
Median 510(k) review, days · DYF
Too few DYF 510(k)s in any year since 2007 to give a median.
Recalls per year · DYF
No recall names DYF since 2007.
Adverse event reports per year · DYF
3in 2025
MAUDE reports naming product code DYF, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K944844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944844: Baxter Reinforced Expanded Ptfe Stepped Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944844
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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