510(k) Report

510(k) · Cleared

Cleared

Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular Graft

K955460510(k) TraditionalCleared May 30, 1996183-day reviewClass II21 CFR 870.3450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Meadox Medicals, Div. Boston Scientific Corp. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on May 30, 1996 as substantially equivalent to K791810 (Impra, Inc., 1979) and 6 other predicates after a 183-day review. Its family tree reaches back 1 generation to 1979. 13 later devices descend from it.

Decided
May 30, 1996
Review
183 days
Class
Class II
Product code
DSY
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K791810 (1979). 7 ancestors in all. 13 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1988: 1 other ancestor1984: 1 other ancestor1983: 1 other ancestor1982: 1 other ancestor1981: 1 other ancestor1997: 1 descendant cleared2006: 1 descendant cleared2013: 2 descendants cleared2008: 1 descendant cleared2016: 1 descendant cleared2012: 2 descendants cleared2009: 1 descendant cleared2026: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant clearedK791810 · Vascular Graft Prost. of Expanded Ptfe · Impra, Inc. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K791810 · Vascular Graft Prost. of Expanded Ptfe · Impra, Inc. · 19790+5
  1. Root · 1 generation backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
  2. This deviceK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
  3. Descendant · cites it directly · 12 of its ownK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  4. Descendant · cites it directly · 11 of its ownK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
  5. Descendant · 2 generations on · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
  6. Descendant · 3 generations on · 6 of its ownK091491 Hero Vascular Access DeviceHemosphere, Inc. · 2009
  7. Descendant · 3 generations on · 5 of its ownK120006 Hero GraftHemosphere, Inc. · 2012

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997: 12006: 12008: 12009: 12012: 22013: 22016: 12017: 12021: 12022: 12026: 1
1997high 2 (2012) · low 0 (1998)2026

Most influential descendants

Showing 5 of 13 · See all
  • K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · cites it directly12descendants
  • K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp · 2006 · cites it directly11descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K791810Vascular Graft Prost. of Expanded PtfeImpra, Inc.1979—
0 (this device)K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular…Meadox Medicals, Div. Boston Scientific Corp.1996—
+1K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.1997—
+1K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted…Boston Scientific Corp20063
+2K071778Hero Vascular Access DeviceGraftcath, Inc.2008—
+3K091491Hero Vascular Access DeviceHemosphere, Inc.2009—
+3K120006Hero GraftHemosphere, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198210
198310
198410
198810
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200610
200810
200910
201220
201320
201610
201710
202110
202210
202610
FIG. 1 — Lineage of K955460, 1979–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K791810Vascular Graft Prost. of Expanded Ptfe
Summary page 1
…Graft Meadox Medicals, [nc , Expanded PTFE Vascular Graft w/External Support Classification Name - Vascular Graft Prosthesis (6 mm and greater) PREDICATE DEVICES: 5 K79 1810 | IMPRA® Vascular Grait IMPRA, Inc. | K81 1510 | GORE-TEXEK FEP Rined Vascular Grafi W.L. Gore & Associates | | K821716 [ Bard® P…
Impra, Inc.1979—
*K811510Gore-Tex Vasular Graft
Summary page 1
…scular Graft w/External Support Classification Name - Vascular Graft Prosthesis (6 mm and greater) PREDICATE DEVICES: 5 K79 1810 | IMPRA® Vascular Grait IMPRA, Inc. | K81 1510 | GORE-TEXEK FEP Rined Vascular Grafi W.L. Gore & Associates | | K821716 [ Bard® PTFE Vascular Prosthesis C.R. Bard, Incorporated…
W. L. Gore & Associates, Inc.1981—
*K821716Bard Ptfe Vascular Prosthesis
Summary page 1
…hesis (6 mm and greater) PREDICATE DEVICES: 5 K79 1810 | IMPRA® Vascular Grait IMPRA, Inc. | K81 1510 | GORE-TEXEK FEP Rined Vascular Grafi W.L. Gore & Associates | | K821716 [ Bard® PTFE Vascular Prosthesis C.R. Bard, Incorporated K83 0806 GORE-TEX®R Vascular Graft W.L. Gore & Associates K84 2144 | GOR…
C.R. Bard, Inc.1982—
*K830806Vascular Graft/Bifurcated/Fep-Ringed
Summary page 1
…® Vascular Grait IMPRA, Inc. | K81 1510 | GORE-TEXEK FEP Rined Vascular Grafi W.L. Gore & Associates | | K821716 [ Bard® PTFE Vascular Prosthesis C.R. Bard, Incorporated K83 0806 GORE-TEX®R Vascular Graft W.L. Gore & Associates K84 2144 | GORE-TEX® Stretch Vascular Graft W L. Gore & Associates | | K880167 |…
W. L. Gore & Associates, Inc.1983—
*K842144Gore-Tex Vascular Graft, Fep-Ringed
Summary page 1
…ined Vascular Grafi W.L. Gore & Associates | | K821716 [ Bard® PTFE Vascular Prosthesis C.R. Bard, Incorporated K83 0806 GORE-TEX®R Vascular Graft W.L. Gore & Associates K84 2144 | GORE-TEX® Stretch Vascular Graft W L. Gore & Associates | | K880167 | GORE-TEX® Removable FEP Ring Gralt W.L. Gore & Associates…
W. L. Gore & Associates, Inc.1984—
*K880167Gore-Tex Vascular Graft
Summary page 1
…cular Prosthesis C.R. Bard, Incorporated K83 0806 GORE-TEX®R Vascular Graft W.L. Gore & Associates K84 2144 | GORE-TEX® Stretch Vascular Graft W L. Gore & Associates | | K880167 | GORE-TEX® Removable FEP Ring Gralt W.L. Gore & Associates | K93 3590 | Baxter RL~inforé&j;lé.fi\finmdfilg’tl?@}‘ alt Baxter Health…
W. L. Gore & Associates, Inc.1988—
*K933590Baxter Reinforced Expanded Ptfe Vascular Graft
Summary page 1
…Graft W.L. Gore & Associates K84 2144 | GORE-TEX® Stretch Vascular Graft W L. Gore & Associates | | K880167 | GORE-TEX® Removable FEP Ring Gralt W.L. Gore & Associates | K93 3590 | Baxter RL~inforé&j;lé.fi\finmdfilg’tl?@}‘ alt Baxter Healthcare. Corp. DEVICE DESCRIPTION: The ePTFE,,; pox Vascular Graft is com…
Baxter Healthcare Corp1994—

Also cleared against K791810: 4 other devices →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.199712
K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp200611

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?

  • None of the 7 ancestors has a recall.
  • Of its descendants, K962433 (Meadox Medicals, Div. Boston Scientific Corp., 1997) has gone furthest, with 12 descendants of its own.
  • 4 other devices also cite its predicate K791810.

How does its category compare?

All DSY devices

DSY 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

2007: 12008: 12009: 52010: 42011: 12012: 42013: 52014: 22015: 12016: 12017: 32018: 12019: 12020: 12021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 5 (2009) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSY

160in 2024

2009: 73 days median2010: 55 days median2012: 30 days median2013: 69 days median2017: 269 days median2024: 160 days median
2007high 269 (2017) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSY

1in 2025

2009: 22010: 52013: 12016: 22025: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSY

151in 2025

2007: 1202008: 1642009: 1932010: 1872011: 1652012: 1772013: 2072014: 3522015: 4602016: 2172017: 1932018: 2002019: 2322020: 1692021: 1682022: 1552023: 1492024: 1532025: 151
2007high 460 (2015) · low 120 (2007)2025

MAUDE reports naming product code DSY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0120
20081—0164
20095732193
20104555187
20111—0165
20124300177
20135691207
20142—0352
20151—0460
20161—2217
201732690193
20181—0200
20191—0232
20201—0169
20212—0168
20222—0155
20232—0149
202451600153
20252—1151
20261—1—

What is it indicated for?

The MEADOX® ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K791810

4 other devices cite the same predicate.

  • K984182Perma-Pass Vascular Graft, 6S Graft,Model 31453, 6T Graft,Model 31452Possis Medical, Inc. · 1999
  • K984183Perma-Pass Vascular Graft, 5T Graft,Model 31451Possis Medical, Inc. · 1999
  • K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  • K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997

More from Meadox Medicals, Div. Boston…

54 FDA decisions under this applicant name. See the company

  • K953647MS Classique Balloon Catheter W/Hydropass CoatingMeadox Medicals, Div. Boston Scientific Corp. · 1997
  • K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  • K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
  • K961847Hemashield Vantage (Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 19971 recall
  • K962342Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 19962 recalls

Recent decisions in DSY

The DSY category page

  • K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
  • K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025
  • K241550Gelweave™ Vascular ProsthesesVascutek, Ltd. · 20251 recall
  • K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 20241 recall
  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024

https://510kreport.com/device/K955460 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955460: Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe 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/K955460

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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