510(k) Report

PMA · Approved

Recalled · Class II · 2015

Gelseal TM Triaxial Vascular Graft

P890045PMAApproved Jan 11, 19931,239-day reviewClass II21 CFR 870.3450Recalls 2

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

Carbomedics, Inc. · MAL Graft, Vascular, Synthetic/Biologic Composite

Approved on Jan 11, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 1,239-day review. 2 later devices descend from it. It has been recalled 2 times.

Decided
Jan 11, 1993
Review
1,239 days
Class
Class II
Product code
MAL
Recalls
2

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceP890045 Gelseal TM Triaxial Vascular GraftCarbomedics, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK162803 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus…Vascutek, Ltd. · 2017
  3. Descendant · 2 generations on · 0 of its ownK241070 Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 2024 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd. · 2017 · cites it directly1descendant
  • K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P890045Gelseal TM Triaxial Vascular GraftCarbomedics, Inc.1993—
+1K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd.2017—
+2K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.20241

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202410
FIG. 1 — Lineage of P890045, 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 PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MAL? 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
Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd.20171

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 15, 2015Class IIZ-1912-2015Error in labelingProduct was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
May 15, 2015Class IIZ-1913-2015Error in labelingProduct was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K162803 (Vascutek, Ltd., 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MAL devices

MAL Graft, Vascular, Synthetic/Biologic Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAL

1in 2012

2010: 12011: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAL

Too few MAL 510(k)s in any year since 2007 to give a median.

Recalls per year · MAL

1in 2022

2010: 32021: 12022: 1
2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · MAL

27in 2025

2007: 142008: 122009: 52010: 72011: 132012: 142013: 342014: 242015: 292016: 202017: 282018: 152019: 282020: 242021: 342022: 212023: 162024: 102025: 27
2007high 34 (2013) · low 5 (2009)2025

MAUDE reports naming product code MAL, 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
20070—014
20080—012
20090—05
20101—37
20111—013
20121—014
20130—034
20140—024
20150—029
20160—020
20170—028
20180—015
20190—028
20200—024
20210—134
20220—121
20230—016
20240—010
20250—027
20260—0—

More from Carbomedics, Inc.

27 FDA decisions under this applicant name. See the company

  • K970375Annuloflo SystemCarbomedics, Inc. · 1997
  • K964665Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997
  • K962154Carbomedics HandleCarbomedics, Inc. · 1996
  • K960923Carbomedics Mitral RotatorCarbomedics, Inc. · 1996
  • K960706Vascutek Vascusoft Plus Vascular GraftCarbomedics, Inc. · 1996

Recent decisions in MAL

The MAL category page

  • K122612Hemashield Woven Double Velour Vascular Graft Model M00202175XXXXX; M00202166XXXXXMaquet Cardiovascular, LLC · 2012
  • K103080Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 201117 Class I recalls
  • K093231Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 201017 Class I recalls
  • K052302Hemashield Platinum Woven Double Velour Taaa Graft ConfigurationBoston Scientific Corp · 20053 recalls
  • K021213Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular GraftsBoston Scientific Corp · 200220 recalls

https://510kreport.com/device/P890045 · printed Nov 4, 2026

Cite this page

510(k) Report. “P890045: Gelseal TM Triaxial Vascular Graft.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P890045

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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