510(k) Report

510(k) · Cleared

Cleared

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

K162803510(k) TraditionalCleared Jul 14, 2017282-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

Vascutek, Ltd. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on Jul 14, 2017 as substantially equivalent to P890045 (Carbomedics, Inc., 1993) and 3 other predicates after a 282-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
Jul 14, 2017
Review
282 days
Class
Class II
Product code
DSY
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to P890045 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2024: 1 descendant clearedP890045 · Gelseal TM Triaxial Vascular Graft · Carbomedics, Inc. · 1993 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant P890045 · Gelseal TM Triaxial Vascular Graft · Carbomedics, Inc. · 1993 · recalled0
  1. Root · 1 generation backP890045 Gelseal TM Triaxial Vascular GraftCarbomedics, Inc. · 1993 · Recalled
  2. This deviceK162803 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus…Vascutek, Ltd. · 2017
  3. Descendant · cites it directly · 0 of its ownK241070 Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 2024 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P890045Gelseal TM Triaxial Vascular GraftCarbomedics, Inc.19932
0 (this device)K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd.2017—
+1K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.20241

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K162803, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (4)

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
*P890045Gelseal TM Triaxial Vascular Graft
Summary page 7
…y marketed device to which equivalence is being claimed: Vascutek Ltd. are claiming equivalence to the following legally marketed devices: • Gelseal™ Vascular Graft (P890045) • Gelsoft™ Vascular Prosthesis (Abdominal Repair Indication) (P890045/S001) • Gelsoft™ Vascular Prosthesis (Peripheral R…
Carbomedics, Inc.19932
*P890045/S001Vascutek Gelsoft (TM) Vascular Graft
Summary page 7
…claiming equivalence to the following legally marketed devices: • Gelseal™ Vascular Graft (P890045) • Gelsoft™ Vascular Prosthesis (Abdominal Repair Indication) (P890045/S001) • Gelsoft™ Vascular Prosthesis (Peripheral Repair Indication) (K990503) • Gelsoft™ Plus Vascular Graft (K955230) Device…
Carbomedics, Inc.1995—
*K990503Sulzer Vascutek Gelsoft Vascular Prosthesis
Summary page 7
…scular Graft (P890045) • Gelsoft™ Vascular Prosthesis (Abdominal Repair Indication) (P890045/S001) • Gelsoft™ Vascular Prosthesis (Peripheral Repair Indication) (K990503) • Gelsoft™ Plus Vascular Graft (K955230) Device Description Gelseal, Gelsoft and Gelsoft Plus vascular prostheses are gelat…
Sulzermedica19991
*K955230Vascutek Gelsoft Plus Vascular Graft
Summary page 7
…r Prosthesis (Abdominal Repair Indication) (P890045/S001) • Gelsoft™ Vascular Prosthesis (Peripheral Repair Indication) (K990503) • Gelsoft™ Plus Vascular Graft (K955230) Device Description Gelseal, Gelsoft and Gelsoft Plus vascular prostheses are gelatin sealed knitted polyester prostheses, desig…
Vascutek, Ltd.19961

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.20240

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?

  • 3 of the 4 ancestors have a recall of any class.
  • Of its descendants, K241070 (Vascutek, Ltd., 2024) has gone furthest, with 0 descendants of its own.

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. 2017, this device’s year, is highlighted.

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?

Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease.

Indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.

Indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

Indications for use as stated in the FDA summary.

More from Vascutek, Ltd.

45 FDA decisions under this applicant name. See the company

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/K162803 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162803: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus 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/K162803

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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