510(k) · Cleared

Cleared

Mantaray Guidewires

K121745510(k) SpecialCleared Jul 13, 201229-day reviewClass II21 CFR 870.1330

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

Bridgepoint Medical · DQX Wire, Guide, Catheter

Cleared on Jul 13, 2012 as substantially equivalent to K120881 (Bridgepoint Medical, 2012) and 1 other predicate after a 29-day review. Its family tree reaches back 11 generations to 1994. 3 of the 61 devices in its family, counting itself, have a Class I recall.

Decided: Jul 13, 2012
Review: 29 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 11 generations to K931794 (1994). 60 ancestors in all, the oldest K884647 (1989). No later device cites it as a predicate yet. 3 of the 61 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 11 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
7 generations between
3 generations backK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
2 generations backK120129 Mantaray CatheterBridgepoint Medical · 2012
1 generation backK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
This deviceK121745 Mantaray GuidewiresBridgepoint Medical · 2012

Show all 11 generations

Root · 11 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
10 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
9 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
8 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
7 generations backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
6 generations backK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
5 generations backK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
4 generations backK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
3 generations backK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
2 generations backK120129 Mantaray CatheterBridgepoint Medical · 2012
1 generation backK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
This deviceK121745 Mantaray GuidewiresBridgepoint Medical · 2012

Class I recalls in this family

K061843 Venture Wire Control Catheter, Model WCC4 generations back · 2006
K042910 Venture Wire Control Catheter, Model WCC5 generations back · 2004
K040922 Venture Wire Control Catheter6 generations back · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K931794	Marinr Series EP Diagnostic Catheters	Medtronic Cardiorhythm	1994	—
−10	K974683	Naviport Deflectable Tip Guiding Catheter	Cardima, Inc.	1999	—
−9	K012749	Biocardia Universal Deflectable Guide Catheter, Model 000664	Biocardia, Inc.	2002	—
−8	K040922	Venture Wire Control Catheter	Velocimed, Inc.	2004	Class I
−7	K042910	Venture Wire Control Catheter, Model WCC	Velocimed, Inc.	2004	Class I
−6	K061843	Venture Wire Control Catheter, Model WCC	St Jude Medical	2006	Class I
−5	K080987	Bridgepoint Medical Stingray Device and Accessories	Bridgepoint Medical	2009	1
−4	K101591	Stingray Orienting Balloon Catheter	Bridgepoint Medical	2010	1
−3	K111963	Bridgepoint Medical Mantaray (TM) Catheter	Bridgepoint Medical	2011	—
−2	K120129	Mantaray Catheter	Bridgepoint Medical	2012	—
−1	K120533	Bigboss Catheters Mantatay Catheter Mantaray Guidewires	Bridgepoint Medical	2012	—
0 (this device)	K121745	Mantaray Guidewires	Bridgepoint Medical	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1991	2	0
1994	1	0
1996	3	0
1997	3	0
1998	4	0
1999	3	0
2000	3	0
2001	4	0
2002	5	0
2003	6	0
2004	3	0
2005	1	0
2008	2	0
2009	3	0
2011	2	0
2012	2	0

FIG. 1 — Lineage of K121745, 1994–2012Source: 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K120881	Mantaray Guidewires Summary page 1 …ed BridgePoint Medical MantarayT rm Guidewires are substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K120881 -Mantaray~m Guidewires K120533 - BridgePoint Medical Peripheral System…	Bridgepoint Medical	2012	—
*	K120533	Bigboss Catheters Mantatay Catheter Mantaray Guidewires Summary page 1 …T rm Guidewires are substantially equivalent in intended use, method of operation and technical aspects to the following predicate device: K120881 -Mantaray~m Guidewires K120533 - BridgePoint Medical Peripheral System Page…	Bridgepoint Medical	2012	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 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.

K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
10 of the 60 ancestors have a recall of any class; 3 have a Class I recall.

How does its category compare?

All DQX devices

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

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121745 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121745: Mantaray Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121745

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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