510(k) · Cleared

Recalled · Class I · 2016

Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR (Product Prefix)

K122937510(k) SpecialCleared Dec 14, 201281-day reviewClass II21 CFR 870.1200Recalls 4 (2 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 Dec 14, 2012 as substantially equivalent to K882796 (Cook, Inc., 1988) after an 81-day review. Its family tree reaches back 1 generation to 1988. 4 of the 11 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 4 times, including 2 Class I recalls.

Decided: Dec 14, 2012
Review: 81 days
Class: Class II
Product code: DQO
Recalls: 4 (2 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K882796 (1988). 9 later devices descend from it, 8 citing it directly. 4 of the 11 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK882796 Slip-Coat (TM) CathetersCook, Inc. · 1988
This deviceK122937 Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle…Cook, Inc. · 2012
Descendant · cites it directly · 1 of its ownK162448 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava…Cook Incorporated · 2017 · Recalled (Class I)
Descendant · cites it directly · 1 of its ownK133130 Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Recalled (Class I)
Descendant · cites it directly · 0 of its ownK181722 Polyethylene CatheterCook Incorporated · 2019
Descendant · cites it directly · 0 of its ownK180286 Polyethylene CatheterCook Incorporated · 2018
Descendant · cites it directly · 0 of its ownK180054 Royal Flush Plus High-Flow CatheterCook Incorporated · 2018

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2015high 4 (2018) · low 0 (2020)2026

Class I recalls in this family

K162448 White Sizing Catheter, Aurous Centimeter Sizing…cites it directly · 2017
K133130 Beacon Tip Torcon NB Advantage Catheter, Torcon…cites it directly · 2015
K173289 Beacon Tip Torcon NB Advantage Catheter…cites it directly · 2017

Most influential descendants

Showing 5 of 9 · See all

K162448White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterCook Incorporated · 2017 · cites it directly1descendant
K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · cites it directly1descendant
K181722Polyethylene CatheterCook Incorporated · 2019 · cites it directly0descendants
K180286Polyethylene CatheterCook Incorporated · 2018 · cites it directly0descendants
K180054Royal Flush Plus High-Flow CatheterCook Incorporated · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882796	Slip-Coat (TM) Catheters	Cook, Inc.	1988	—
0 (this device)	K122937	Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select…	Cook, Inc.	2012	—
+1	K162448	White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing…	Cook Incorporated	2017	Class I
+1	K133130	Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter	Cook, Inc.	2015	Class I
+1	K181722	Polyethylene Catheter	Cook Incorporated	2019	—
+1	K180286	Polyethylene Catheter	Cook Incorporated	2018	—
+1	K180054	Royal Flush Plus High-Flow Catheter	Cook Incorporated	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	1
2016	1	0
2017	2	2
2018	4	0
2019	1	0

FIG. 1 — Lineage of K122937, 1988–2019Source: 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.

4 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? (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
*	K882796	Slip-Coat (TM) Catheters Summary page 1 …ices,subject of this submnission, are substantially equivalentto the Slip-CoatTh Catheters, manufactured by Cook Incorporated, which, are; cleared; under 510O(k), number K882796 and the reference device, Cantata Microcatheter, which is cleared under 510()fnumberK101I450. Comparison to Predicate and 'Refer…	Cook, Inc.	1988	—
†	K101450	Cantata Microcatheter	Cook, Inc.	2010	—

Also cleared against K882796: 2 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K162448	White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter Class I	Cook Incorporated	2017	1
K133130	Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter Class I	Cook, Inc.	2015	1
K181722	Polyethylene Catheter	Cook Incorporated	2019	0
K180286	Polyethylene Catheter	Cook Incorporated	2018	0
K180054	Royal Flush Plus High-Flow Catheter	Cook Incorporated	2018	0
K172635	High-Flo Silver Polyethylene Catheter	Cook Incorporated	2018	0
K171264	Royal Flush Catheter	Cook Incorporated	2018	0
K173289	Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle… Class I	Cook Incorporated	2017	0

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 15, 2016	Class II	Z-2614-2016	Unknown/Undetermined by firm	Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or…
Apr 15, 2016	Class II	Z-2613-2016	Unknown/Undetermined by firm	Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or…
Oct 7, 2015	Class I	Z-0798-2016	Component design/selection	Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded…
Jul 2, 2015	Class I	Z-2319-2015	Component design/selection	Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

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.

K162448White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterCook Incorporated · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath…Cook Incorporated · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K162448 (Cook Incorporated, 2017) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K882796.

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

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 angiographic procedures by physicians trained and experienced in angiographic techniques.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122937 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122937: Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR (Product Prefix).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122937

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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