510(k) · Cleared

Cleared

NC Quantum Apex Ptca Dilatation Catheter (Monorail)

K121667510(k) SpecialCleared Aug 13, 201268-day reviewClass II21 CFR 870.5100

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

Boston Scientific Corp · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cleared on Aug 13, 2012 as substantially equivalent to P860019 (Scimed Life Systems, Inc., 1986) after a 68-day review. Its family tree reaches back 1 generation to 1986. 8 later devices descend from it.

Decided: Aug 13, 2012
Review: 68 days
Class: Class II
Product code: LOX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P860019 (1986). 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
This deviceK121667 NC Quantum Apex Ptca Dilatation Catheter (Monorail)Boston Scientific Corp · 2012
Descendant · cites it directly · 3 of its ownK141236 NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca…Boston Scientific Corporation · 2014 · Recalled
Descendant · cites it directly · 1 of its ownK162434 NC Gallant PTCA CatheterMedinol, Ltd. · 2017
Descendant · 2 generations on · 0 of its ownK223189 Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2023
Descendant · 2 generations on · 0 of its ownK222538 NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2022
Descendant · 2 generations on · 0 of its ownK211393 Selethru (TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014high 1 (2014) · low 0 (2019)2026

Most influential descendants

Showing 5 of 8 · See all

K141236NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter…Boston Scientific Corporation · 2014 · cites it directly3descendants
K162434NC Gallant PTCA CatheterMedinol, Ltd. · 2017 · cites it directly1descendant
K223189Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2023 · 2 generations on0descendants
K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2022 · 2 generations on0descendants
K211393Selethru (TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P860019	Scimed Ptca Dilatation Catheter	Scimed Life Systems, Inc.	1986	5
0 (this device)	K121667	NC Quantum Apex Ptca Dilatation Catheter (Monorail)	Boston Scientific Corp	2012	—
+1	K141236	NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation…	Boston Scientific Corporation	2014	1
+1	K162434	NC Gallant PTCA Catheter	Medinol, Ltd.	2017	—
+2	K223189	Firefighter™ NC Pro PTCA Balloon Catheter	Shanghai MicroPort Medical (Group) Co., Ltd.	2023	—
+2	K222538	NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter	Sino Medical Sciences Technology, Inc.	2022	—
+2	K211393	Selethru (TM) NC PTCA Balloon Dilatation Catheter	Kossel Medtech (Suzhou) Co., Ltd.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2021	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K121667, 1986–2023Source: 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.

Planning a device in LOX? 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 LOX device

#1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	P860019	Scimed Ptca Dilatation Catheter Summary page 1 …CA) Dilatation Catheter Product Code LOX Classification Class 11,21 CFR Part 870.5100 Predicate NC Quantum ApeXTM PTCA P860019 16 April 2010 Device Dilatation Catheter /S241 Reference Emerge T M PTCA Dilatat…	Scimed Life Systems, Inc.	1986	5
†	K113220	Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)	Boston Scientific Corporation	2012	1

Also cleared against P860019: 20 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K141236	NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter…	Boston Scientific Corporation	2014	3
K162434	NC Gallant PTCA Catheter	Medinol, Ltd.	2017	1
K160823	NC Quantum Apex PTCA Dilatation Catheter	Boston Scientific Corporation	2016	0
K143160	FOXTROT NC PTCA Balloon Catheter	Shanghai MicroPort Medical (Group) Co., Ltd.	2015	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K141236 (Boston Scientific Corporation, 2014) has gone furthest, with 3 descendants of its own.
20 other devices also cite its predicate P860019.

How does its category compare?

All LOX devices

LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LOX

4in 2024

2007high 32 (2010) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOX

241in 2024

2007high 241 (2024) · low 80 (2018)2026

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

Recalls per year · LOX

4in 2019

2007high 80 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOX

1,890in 2025

2007high 2,753 (2017) · low 1,053 (2007)2025

MAUDE reports naming product code LOX, 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	19	—	1	1,053
2008	22	—	80	1,063
2009	28	—	0	1,353
2010	32	—	0	1,392
2011	9	103	0	2,090
2012	10	120	0	2,092
2013	6	123	0	2,436
2014	6	166	0	2,316
2015	4	119	0	2,060
2016	9	116	0	2,578
2017	6	113	0	2,753
2018	7	80	0	2,225
2019	1	—	4	2,102
2020	1	—	0	1,974
2021	6	167	0	1,738
2022	5	121	0	1,816
2023	4	138	0	1,720
2024	4	241	0	1,804
2025	0	—	0	1,890
2026	6	156	0	—

What is it indicated for?

The NC Quantum Apex Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121667: NC Quantum Apex Ptca Dilatation Catheter (Monorail).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121667

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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