510(k) · Cleared

Recalled · Class I · 2019

Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter

K133130510(k) TraditionalCleared Jan 9, 2015466-day reviewClass II21 CFR 870.1200Recalls 73 (1 Class I)

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

Cook, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Jan 9, 2015 as substantially equivalent to K122937 (Cook, Inc., 2012) and 2 other predicates after a 466-day review. Its family tree reaches back 2 generations to 2001. 3 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 73 times, including a Class I recall.

Decided: Jan 9, 2015
Review: 466 days
Class: Class II
Product code: DQO
Recalls: 73 (1 Class I)
Predicates: 3

Its longest line of descent runs back 2 generations to K011664 (2001). 5 ancestors in all, the oldest K882796 (1988). 1 later device descends from it, 1 citing it directly. 3 of the 7 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK011664 Imager II Angiographic CatheterBoston Scientific/Medi-Tech · 2001 · Recalled
1 generation backK121694 Imager II Angiographic CatheterBoston Scientific Corp · 2012 · Recalled (Class I)
This deviceK133130 Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015
Descendant · cites it directly · 0 of its ownK161822 Torcon NB Advantage CathetersCook Incorporated · 2016

Class I recalls in this family

K122937 Slip-Cath Beacon Tip Catheter Model SCBR…direct predicate · 2012
K121694 Imager II Angiographic Catheterdirect predicate · 2012

Most influential descendants

Showing 1 of 1 · See all

K161822Torcon NB Advantage CathetersCook Incorporated · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K011664	Imager II Angiographic Catheter	Boston Scientific/Medi-Tech	2001	2
−1	K121694	Imager II Angiographic Catheter	Boston Scientific Corp	2012	Class I
0 (this device)	K133130	Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter	Cook, Inc.	2015	—
+1	K161822	Torcon NB Advantage Catheters	Cook Incorporated	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
2002	1	0
2012	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K133130, 2001–2016Source: 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.

3 devices in this family have 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 DQO device

#1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K122937	Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath… Summary page 4 …eacon Tip Catheters and the Shuttle® Select Slip-Cath® Catheters, and the Slip- Coat™ Catheters manufactured by Cook Incorporated, which are cleared under 510(k) numbers K122937 and K882796, respectively. They are also substantially equivalent to the Imager II 5F Selective Angiography Catheter manufactured…	Cook, Inc.	2012	Class I
*	K882796	Slip-Coat (TM) Catheters Summary page 4 …theters and the Shuttle® Select Slip-Cath® Catheters, and the Slip- Coat™ Catheters manufactured by Cook Incorporated, which are cleared under 510(k) numbers K122937 and K882796, respectively. They are also substantially equivalent to the Imager II 5F Selective Angiography Catheter manufactured by Boston S…	Cook, Inc.	1988	—
*	K121694	Imager II Angiographic Catheter Summary page 4 …are also substantially equivalent to the Imager II 5F Selective Angiography Catheter manufactured by Boston Scientific Corporation, which is cleared under 510(k) number K121694. K133130, 510k Summary, Page 2 of 3 Comparison to Predica…	Boston Scientific Corp	2012	Class I

Also cleared against K122937: 7 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K161822	Torcon NB Advantage Catheters	Cook Incorporated	2016	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 21, 2019	Class II	Z-0435-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0468-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0453-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0447-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0459-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0443-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0445-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0460-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0472-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0465-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0438-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0463-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0427-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0430-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0448-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0441-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0451-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0467-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0432-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0470-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0457-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0458-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0433-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0462-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0421-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0437-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0466-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0426-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0440-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0444-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0428-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0442-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0434-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0431-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0439-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0449-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0461-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0454-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0446-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0452-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0450-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0424-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0455-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0456-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0464-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0422-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0425-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0436-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0423-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Oct 21, 2019	Class II	Z-0429-2020	Process change control	The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

The 5 latest of 50 recalls; the web page lists all.

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.

K122937Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR…Cook, Inc. · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
K121694Imager II Angiographic CatheterBoston Scientific Corp · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K161822 (Cook Incorporated, 2016) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K122937.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DQO

2in 2025

2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	106	14	564
2008	3	80	4	726
2009	8	58	7	933
2010	7	137	11	556
2011	6	74	7	625
2012	15	94	2	532
2013	2	—	1	753
2014	3	109	0	601
2015	10	209	1 (1)	628
2016	4	89	2 (1)	614
2017	10	176	1	873
2018	10	234	2	777
2019	6	113	71	386
2020	3	30	4 (4)	312
2021	1	—	0	338
2022	4	181	1	379
2023	4	73	1 (1)	391
2024	4	148	0	511
2025	2	—	0	656
2026	3	85	24 (4)	—

What is it indicated for?

The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133130 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133130: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133130

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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