510(k) · Cleared

Cleared

Modification to Vascular Solutions Pronto Extraction Catheter

K042937510(k) SpecialCleared Jan 31, 200598-day reviewClass II21 CFR 870.5150

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

Vascular Solutions, Inc. · QEZ Aspiration Thrombectomy Catheter

Cleared on Jan 31, 2005 as substantially equivalent to K032763 (Vascular Solutions, Inc., 2003) after a 98-day review. Its family tree reaches back 1 generation to 2003. 1 of the 20 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it.

Decided: Jan 31, 2005
Review: 98 days
Class: Class II
Product code: QEZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032763 (2003). 18 later devices descend from it, 4 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK032763 Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2003 · Recalled
This deviceK042937 Modification to Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2005
Descendant · cites it directly · 10 of its ownK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
Descendant · 2 generations on · 9 of its ownK071529 Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · Recalled
Descendant · 3 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
Descendant · 3 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
Descendant · cites it directly · 3 of its ownK062172 Fetch Aspiration CatheterPossis Medical, Inc. · 2006

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006high 5 (2008) · low 0 (2009)2026

Class I recalls in this family

K101354 Fetch 2 Aspiration Catheter Model 109400-0013 generations on · 2011

Most influential descendants

Showing 5 of 18 · See all

K053372Lbi Catheter SystemLumen Biomedical, Inc. · 2006 · cites it directly10descendants
K071529Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · 2 generations on9descendants
K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 3 generations on6descendants
K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 3 generations on5descendants
K062172Fetch Aspiration CatheterPossis Medical, Inc. · 2006 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032763	Vascular Solutions Pronto Extraction Catheter	Vascular Solutions, Inc.	2003	1
0 (this device)	K042937	Modification to Vascular Solutions Pronto Extraction Catheter	Vascular Solutions, Inc.	2005	—
+1	K053372	Lbi Catheter System	Lumen Biomedical, Inc.	2006	—
+2	K071529	Xtract Catheter System	Lumen Biomedical, Inc.	2007	1
+3	K080901	Lbi Embolectomy System	Lumen Biomedical, Inc.	2008	—
+3	K113757	Aspire Max Aspiration Catheter	Control Medical Technology, LLC	2012	—
+1	K062172	Fetch Aspiration Catheter	Possis Medical, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	3	0
2007	2	0
2008	5	0
2011	2	1
2012	1	0
2020	2	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K042937, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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 QEZ device

#1 K253925 Aventus Thrombectomy Systemscore 17.9 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K032763	Vascular Solutions Pronto Extraction Catheter Summary page 6 …Summary of Clinical Testing: No clinical evaluations of this product for this use have been conducted. Predicate Devices: Currently marketed Pronto Extraction Catheter (K032763) Conclusions: The modified Pronto is substantially equivalent to the currently marketed Vascular Solutions Inc. Pronto Extractio…	Vascular Solutions, Inc.	2003	1

Also cleared against K032763: 7 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K053372	Lbi Catheter System	Lumen Biomedical, Inc.	2006	10
K062172	Fetch Aspiration Catheter	Possis Medical, Inc.	2006	3
K070363	Fetch Aspiration Catheter	Possis Medical, Inc.	2007	2
K052523	Proxis System	Velocimed, Inc.	2006	2

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K053372 (Lumen Biomedical, Inc., 2006) has gone furthest, with 10 descendants of its own.
7 other devices also cite its predicate K032763.

How does its category compare?

All QEZ devices

QEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEZ

5in 2025

2007high 11 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEZ

108in 2025

2007high 144 (2013) · low 33 (2010)2026

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

Recalls per year · QEZ

No recall names QEZ since 2007.

Adverse event reports per year · QEZ

21in 2025

2007high 21 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	11	79	0
2008	6	72	0
2009	4	83	0
2010	3	33	0
2011	7	118	0
2012	5	90	0
2013	4	144	0
2014	1	—	0
2015	0	—	0
2016	1	—	0
2017	3	112	0
2018	1	—	0
2019	3	94	0
2020	3	120	0
2021	3	53	2
2022	2	—	18
2023	1	—	14
2024	1	—	17
2025	5	108	21
2026	6	98	—

What is it indicated for?

The Vascular Solutions Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial systems.

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

https://510kreport.com/device/K042937 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042937: Modification to Vascular Solutions Pronto Extraction Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042937

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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