510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Angiodynamics Soft-VU Angiographic Catheters

K112452510(k) SpecialCleared Mar 30, 2012218-day reviewClass II21 CFR 870.1200Recalls 20

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

AngioDynamics, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Mar 30, 2012 after a 218-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled 20 times.

Decided
Mar 30, 2012
Review
218 days
Class
Class II
Product code
DQO
Recalls
20
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared2010201520202025
  1. This deviceK112452 Angiodynamics Soft-VU Angiographic CathetersAngioDynamics, Inc. · 2012
  2. Descendant · cites it directly · 2 of its ownK151724 AngioDynamics Mariner Angiographic CathetersAngioDynamics, Inc. · 2015
  3. Descendant · cites it directly · 1 of its ownK161596 Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersAngioDynamics, Inc. · 2017 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK173762 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc. · 2018 · Recalled
  5. Descendant · cites it directly · 0 of its ownK122506 Surefire High Flow Angiographic Catheter, AccessSurefire Medical, Inc. · 2012

Most influential descendants

Showing 4 of 4 · See all
  • K151724AngioDynamics Mariner Angiographic CathetersAngioDynamics, Inc. · 2015 · cites it directly2descendants
  • K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersAngioDynamics, Inc. · 2017 · cites it directly1descendant
  • K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc. · 2018 · 2 generations on0descendants
  • K122506Surefire High Flow Angiographic Catheter, AccessSurefire Medical, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K112452Angiodynamics Soft-VU Angiographic CathetersAngioDynamics, Inc.2012—
+1K151724AngioDynamics Mariner Angiographic CathetersAngioDynamics, Inc.2015—
+1K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersAngioDynamics, Inc.201720
+2K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc.201818
+1K122506Surefire High Flow Angiographic Catheter, AccessSurefire Medical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
201710
201810
FIG. 1 — Lineage of K112452, 2012–2018Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K151724AngioDynamics Mariner Angiographic CathetersAngioDynamics, Inc.20152
K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersAngioDynamics, Inc.20171
K122506Surefire High Flow Angiographic Catheter, AccessSurefire Medical, Inc.20120

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 3, 2026Class IIZ-1861-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1874-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1859-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1872-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1866-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1864-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1868-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1875-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1863-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1867-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1858-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1856-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1871-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1860-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1862-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1869-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1870-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1873-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Mar 3, 2026Class IIZ-1865-2026Nonconforming Material/ComponentThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Sep 22, 2017Class IIZ-0742-2018Process controlProduct was placed into distribution prior to completion of all required post sterilization release activities.

The 5 latest of 20 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K151724 (AngioDynamics, Inc., 2015) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Indications for use as stated in the FDA 510(k) statement.

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87 FDA decisions under this applicant name. See the company

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  • K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsAngioDynamics, Inc. · 2023

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K112452 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112452: Angiodynamics Soft-VU Angiographic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112452

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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