510(k) · Cleared

Cleared

Sapphire NC

K103808510(k) TraditionalCleared Sep 1, 2011246-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

Orbusneich Medical, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cleared on Sep 1, 2011 as substantially equivalent to P790017 (Medtronic, Ireland, 1980) and 3 other predicates after a 246-day review. Its family tree reaches back 1 generation to 1980. 11 later devices descend from it.

Decided: Sep 1, 2011
Review: 246 days
Class: Class II
Product code: LOX
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to P790017 (1980). 4 ancestors in all. 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
This deviceK103808 Sapphire NCOrbusneich Medical, Inc. · 2011
Descendant · cites it directly · 9 of its ownK162209 Sapphire NC PlusOrbusneich Medical, Inc. · 2016
Descendant · cites it directly · 4 of its ownK163114 Sapphire II PROOrbusneich Medical, Inc. · 2017
Descendant · 2 generations on · 3 of its ownK192344 Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc. · 2019
Descendant · 2 generations on · 1 of its ownK211807 Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd. · 2021
Descendant · 2 generations on · 1 of its ownK173680 Sapphire II PROOrbusneich Medical Trading, Inc. · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2016high 3 (2021) · low 0 (2020)2026

Most influential descendants

Showing 5 of 11 · See all

K162209Sapphire NC PlusOrbusneich Medical, Inc. · 2016 · cites it directly9descendants
K163114Sapphire II PROOrbusneich Medical, Inc. · 2017 · cites it directly4descendants
K192344Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc. · 2019 · 2 generations on3descendants
K211807Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd. · 2021 · 2 generations on1descendant
K173680Sapphire II PROOrbusneich Medical Trading, Inc. · 2018 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P790017	Usci Dilatation Catheter	Medtronic, Ireland	1980	—
0 (this device)	K103808	Sapphire NC	Orbusneich Medical, Inc.	2011	—
+1	K162209	Sapphire NC Plus	Orbusneich Medical, Inc.	2016	—
+1	K163114	Sapphire II PRO	Orbusneich Medical, Inc.	2017	—
+2	K192344	Sapphire NC Plus Coronary Dilatation Catheter	Orbusneich Medical Trading, Inc.	2019	—
+2	K211807	Sapphire NC 24	OrbusNeich Medical (Shenzhen) Co., Ltd.	2021	—
+2	K173680	Sapphire II PRO	Orbusneich Medical Trading, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1986	1	0
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0
2018	2	0
2019	1	0
2021	3	0
2023	1	0
2024	2	0

FIG. 1 — Lineage of K103808, 1980–2024Source: 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? (4)

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
*	P790017	Usci Dilatation Catheter The summary prints P790017, a PMA number, which our reading took as K790017. Corrected to the number the summary prints.	Medtronic, Ireland	1980	—
*	P810046	Simpson-Robert Coronary Balloon Dilatation Cathete The summary prints P810046, a PMA number, which our reading took as K810046. Corrected to the number the summary prints.	Advanced Cardiovascular Systems, Inc.	1982	4
*	P860019	Scimed Ptca Dilatation Catheter The summary prints P860019, a PMA number, which our reading took as K860019. Corrected to the number the summary prints.	Scimed Life Systems, Inc.	1986	5
*	P880003	Cordis Ptca Dilatation Catheter The summary prints P880003, a PMA number, which our reading took as K880003. Corrected to the number the summary prints.	Cordis Corp.	1988	80

Also cleared against P790017: 12 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K162209	Sapphire NC Plus	Orbusneich Medical, Inc.	2016	9
K163114	Sapphire II PRO	Orbusneich Medical, Inc.	2017	4
K230374	Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon…	Dongguan TT Medical, Inc.	2023	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?

3 of the 4 ancestors have a recall of any class.
Of its descendants, K162209 (Orbusneich Medical, Inc., 2016) has gone furthest, with 9 descendants of its own.
12 other devices also cite its predicate P790017.

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. 2011, 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 Sapphire NC Coronary Dilatation Catheter is indicated for:

* balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemnia for the purpose of improving myocardial perfusion

* balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

* in-stent restenosis

* post-delivery expansion of balloon expandable coronary stents

Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) Alloy Stent. All stents should be deployed in accordance with the manufacturer's indications and instructions for use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103808: Sapphire NC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103808

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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