510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters

K161596510(k) TraditionalCleared Apr 28, 2017323-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 Apr 28, 2017 as substantially equivalent to K151724 (AngioDynamics, Inc., 2015) and 1 other predicate after a 323-day review. Its family tree reaches back 2 generations to 2012. 1 later device descends from it. It has been recalled 20 times.

Decided
Apr 28, 2017
Review
323 days
Class
Class II
Product code
DQO
Recalls
20
Predicates
2

Its longest line of descent runs back 2 generations to K112452 (2012). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant clearedK112452 · Angiodynamics Soft-VU Angiographic Catheters · AngioDynamics, Inc. · 2012 · recalledK151724 · AngioDynamics Mariner Angiographic Catheters · AngioDynamics, Inc. · 20152010201520202025
Descendants, by generation 1 generation forward: 1 descendant K151724 · AngioDynamics Mariner Angiographic Catheters · AngioDynamics, Inc. · 2015K112452 · Angiodynamics Soft-VU Angiographic Catheters · AngioDynamics, Inc. · 2012 · recalled0
  1. Root · 2 generations backK112452 Angiodynamics Soft-VU Angiographic CathetersAngioDynamics, Inc. · 2012 · Recalled
  2. 1 generation backK151724 AngioDynamics Mariner Angiographic CathetersAngioDynamics, Inc. · 2015
  3. This deviceK161596 Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersAngioDynamics, Inc. · 2017
  4. Descendant · cites it directly · 0 of its ownK173762 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc. · 2018 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K112452Angiodynamics Soft-VU Angiographic CathetersAngioDynamics, Inc.201220
−1K151724AngioDynamics Mariner Angiographic CathetersAngioDynamics, Inc.2015—
0 (this device)K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersAngioDynamics, Inc.2017—
+1K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc.201818

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K161596, 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 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 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? (2)

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
*K151724AngioDynamics Mariner Angiographic Catheters
Summary page 4
…tic (21CFR§870.1200, Class II, Pro-Code DQO) Classification Panel: Cardiovascular Premarket Notification: K151724, K112452 1 Angio…
AngioDynamics, Inc.2015—
*K112452Angiodynamics Soft-VU Angiographic Catheters
Summary page 4
…(21CFR§870.1200, Class II, Pro-Code DQO) Classification Panel: Cardiovascular Premarket Notification: K151724, K112452 1 AngioDynamics…
AngioDynamics, Inc.201220

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc.20180

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-1857-2026Nonconforming 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.

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?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K173762 (AngioDynamics, Inc., 2018) has gone furthest, with 0 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. 2017, 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 summary.

More from AngioDynamics, Inc.

87 FDA decisions under this applicant name. See the company

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  • K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090)…AngioDynamics, Inc. · 2024
  • K240397AlphaVac MMA F1885 System (H787253020)AngioDynamics, Inc. · 2024
  • 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/K161596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161596: Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161596

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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