510(k) · Cleared
ClearedHero Vascular Access Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemosphere, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Jul 31, 2009 as substantially equivalent to K071778 (Graftcath, Inc., 2008) after a 72-day review. Its family tree reaches back 5 generations to 1979. 6 later devices descend from it.
- Decided
- Jul 31, 2009
- Review
- 72 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K791810 (1979). 17 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
- 4 generations backK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
- 3 generations backK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
- 2 generations backK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
- 1 generation backK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
- This deviceK091491 Hero Vascular Access DeviceHemosphere, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK120006 Hero GraftHemosphere, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK121532 Hero GraftHemosphere, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK124039 Hero GraftHemoshpere, Inc., A Cryolife Company · 2013
- Descendant · 2 generations on · 2 of its ownK172637 HeRO GraftMerit Medical Systems, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK203724 HeRO Graft, HeRO AdapterMerit Medical Systems, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120006Hero GraftHemosphere, Inc. · 2012 · cites it directly5descendants
- K121532Hero GraftHemosphere, Inc. · 2012 · cites it directly4descendants
- K124039Hero GraftHemoshpere, Inc., A Cryolife Company · 2013 · cites it directly3descendants
- K172637HeRO GraftMerit Medical Systems, Inc. · 2017 · 2 generations on2descendants
- K203724HeRO Graft, HeRO AdapterMerit Medical Systems, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K791810 | Vascular Graft Prost. of Expanded Ptfe | Impra, Inc. | 1979 | — |
| −4 | K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular… | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| −3 | K962433 | Meadox Exxcel Eptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
| −2 | K052964 | Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted… | Boston Scientific Corp | 2006 | 3 |
| −1 | K071778 | Hero Vascular Access Device | Graftcath, Inc. | 2008 | — |
| 0 (this device) | K091491 | Hero Vascular Access Device | Hemosphere, Inc. | 2009 | — |
| +1 | K120006 | Hero Graft | Hemosphere, Inc. | 2012 | — |
| +1 | K121532 | Hero Graft | Hemosphere, Inc. | 2012 | — |
| +1 | K124039 | Hero Graft | Hemoshpere, Inc., A Cryolife Company | 2013 | — |
| +2 | K172637 | HeRO Graft | Merit Medical Systems, Inc. | 2017 | — |
| +3 | K203724 | HeRO Graft, HeRO Adapter | Merit Medical Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 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 12.5 · 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? (1)
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 |
|---|---|---|---|
| * | K071778 | Hero Vascular Access DeviceSummary page 1…21 CFR 870.3450; Vascular access prosthesis; II; DSY, LJS, MSD, Cardiology K071778, HeRO TM Vascular Access Device Predicate Device: Manufacturer:… | 2008 |
What descends from it? (6)
3 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 30 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K120006 (Hemosphere, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K071778.
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. 2009, this device’s year, is highlighted.
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 HeROTM Vascular Access Device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the K/DOQI guidelines1 as patients who: * Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts). * Are not candidates for upper extremity…
Read the full statement (171 words)
The HeROTM Vascular Access Device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the K/DOQI guidelines1 as patients who:
* Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
* Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
* Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography.
* Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
- Have a compromised central venous system or central venous stenosis (CVS) as determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
* Are receiving inadequate dialysis clearance (i.e., low KtW) via catheters. K/DOQI guidelines recommend a minimum Kt/V of 1.4.2
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091491 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091491: Hero Vascular Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091491
Report an extraction error
Are you the manufacturer?
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