510(k) Report

PMA · Approved

Approved

Quickseal Femoral Arterial Closure System

P010049PMAApproved Mar 25, 2002196-day reviewClass III

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

Sub-Q, Inc. · MGB Device, Hemostasis, Vascular

Approved on Mar 25, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 196-day review. 1 later device descends from it.

Decided
Mar 25, 2002
Review
196 days
Class
Class III
Product code
MGB
Recalls
None

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared200020052010201520202025
  1. This deviceP010049 Quickseal Femoral Arterial Closure SystemSub-Q, Inc. · 2002
  2. Descendant · cites it directly · 0 of its ownK050135 K-C Hemostatic Biopsy SystemBioengineering Consultants, Ltd. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K050135K-C Hemostatic Biopsy SystemBioengineering Consultants, Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P010049Quickseal Femoral Arterial Closure SystemSub-Q, Inc.2002—
+1K050135K-C Hemostatic Biopsy SystemBioengineering Consultants, Ltd.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of P010049, 2002–2005Source: 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 MGB? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K050135K-C Hemostatic Biopsy SystemBioengineering Consultants, Ltd.20050

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, K050135 (Bioengineering Consultants, Ltd., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MGB devices

MGB Device, Hemostasis, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGB

18in 2025

2007: 182008: 202009: 342010: 222011: 232012: 162013: 122014: 262015: 282016: 262017: 152018: 232019: 272020: 102021: 172022: 112023: 182024: 222025: 182026 (partial year): 24
2007high 34 (2009) · low 10 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MGB

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

Recalls per year · MGB

2in 2023

2009: 12012: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

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

Adverse event reports per year · MGB

12,664in 2025

2007: 1,5882008: 2,2672009: 2,4362010: 3,9332011: 4,0112012: 3,7862013: 3,0112014: 4,4682015: 3,9442016: 4,3302017: 5,3462018: 5,6792019: 6,1562020: 5,9272021: 7,5862022: 9,4572023: 13,5292024: 13,7622025: 12,664
2007high 13,762 (2024) · low 1,588 (2007)2025

MAUDE reports naming product code MGB, 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
200718—01,588
200820—02,267
200934—12,436
201022—03,933
201123—04,011
201216—13,786
201312—03,011
201426—04,468
201528—03,944
201626—04,330
201715—05,346
201823—05,679
201927—06,156
202010—05,927
202117—07,586
202211—09,457
202318—213,529
202422—013,762
202518—012,664
202624—0—

More from Sub-Q, Inc.

14 FDA decisions under this applicant name. See the company

  • P010049/S012Surestat Arterial Closure SystemSub-Q, Inc. · 2004
  • P010049/S011Quickseal Surestat Arterial Closure SystemSub-Q, Inc. · 2004
  • P010049/S010Quickseal Sureshot Arterial Closure SystemSub-Q, Inc. · 2004
  • P010049/S009Quickseal Control Femoral Arterial Closure SystemSub-Q, Inc. · 2003
  • P010049/S008Quickseal Control Arterial Closure SystemSub-Q, Inc. · 2003

Recent decisions in MGB

The MGB category page

  • P250015PerQseal® Elite Vascular Closure DeviceVivasure Medical, Ltd. · 2026
  • P960043/S137Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair SystemAbbott Vascular, Inc. · 2026
  • P120016/S043VASCADE 5F Vascular Closure SystemCardiva Medical, Inc. · 2026
  • P960043/S128Perclose ProGlide Suture-Mediated Closure System and Perclose ProStyle Suture-Mediated Closure and Repair…Abbott Vascular, Inc. · 2026
  • P930038/S107Angio Seal VIP Vascular Closure DeviceTerumo Medical Corporation · 2026

https://510kreport.com/device/P010049 · printed Nov 5, 2026

Cite this page

510(k) Report. “P010049: Quickseal Femoral Arterial Closure System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P010049

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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