510(k) · Cleared
ClearedSapphire NC Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orbusneich Medical, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Oct 6, 2016 as substantially equivalent to K103808 (Orbusneich Medical, Inc., 2011) after a 62-day review. Its family tree reaches back 2 generations to 1980. 9 later devices descend from it.
- Decided
- Oct 6, 2016
- Review
- 62 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P790017 (1980). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 1 generation backK103808 Sapphire NCOrbusneich Medical, Inc. · 2011
- This deviceK162209 Sapphire NC PlusOrbusneich Medical, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK163114 Sapphire II PROOrbusneich Medical, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK192344 Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc. · 2019
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK233499 Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K163114Sapphire II PROOrbusneich Medical, Inc. · 2017 · cites it directly4descendants
- K192344Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc. · 2019 · cites it directly3descendants
- K211807Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd. · 2021 · cites it directly1descendant
- K173680Sapphire II PROOrbusneich Medical Trading, Inc. · 2018 · 2 generations on1descendant
- K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024 · 2 generations on0descendants
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 | K103808 | Sapphire NC | Orbusneich Medical, Inc. | 2011 | — |
| 0 (this device) | K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | 2016 | — |
| +1 | K163114 | Sapphire II PRO | Orbusneich Medical, Inc. | 2017 | — |
| +1 | K192344 | Sapphire NC Plus Coronary Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2019 | — |
| +1 | K211807 | Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021 | — |
| +2 | K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018 | — |
| +2 | K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2024 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K103808 | Sapphire NCSummary page 4…luminal coronary angioplasty, percutaneous (21 CFR 870.5100(a), Product Code LOX) Predicate Device: Sapphire NC (K103808; cleared September 7, 2011) Device Description: The Sapphire NC Plus coronary dilatation catheter is a percutan… | 2011 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 36 years and passes through 2 companies; a new generation was cleared every 31.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K163114 (Orbusneich Medical, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K103808.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 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 Plus Coronary Dilatation Catheter is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia 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/K162209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162209: Sapphire NC Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162209
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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