510(k) · Cleared

Cleared

OPN NC PTCA Dilatation Catheter

K212393510(k) TraditionalCleared Mar 14, 2022224-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

Sis Medical AG · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cleared on Mar 14, 2022 as substantially equivalent to K141090 (Medtronic, Inc., 2014) after a 224-day review. Its family tree reaches back 2 generations to 1980.

Decided: Mar 14, 2022
Review: 224 days
Class: Class II
Product code: LOX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to P790017 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
1 generation backK141090 NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc. · 2014
This deviceK212393 OPN NC PTCA Dilatation CatheterSis Medical AG · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P790017	Usci Dilatation Catheter	Medtronic, Ireland	1980	—
−1	K141090	NC Euphora Rapid Exchange Balloon Dilatation Catheter	Medtronic, Inc.	2014	—
0 (this device)	K212393	OPN NC PTCA Dilatation Catheter	Sis Medical AG	2022	—

FIG. 1 — Lineage of K212393, 1980–2022Source: 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
*	K141090	NC Euphora Rapid Exchange Balloon Dilatation Catheter Summary page 4 …LOX Predicate Devices: NC Euphora Rapid Exchange Balloon Dilatation Catheter, K141090 INTENDED USE/INDICATIONS FOR USE: The OPN NC PTCA Dilatation Catheter is intended for balloon dilatation of…	Medtronic, Inc.	2014	—

Also cleared against K141090: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 42 years and passes through 3 companies; a new generation was cleared every 34.4 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K141090.

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. 2022, 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 OPN NC PTCA Dilatation Catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable coronary stents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K212393 · printed Nov 4, 2026

Cite this page

510(k) Report. “K212393: OPN NC PTCA Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212393

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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