510(k) · Cleared
ClearedSapphire II PRO
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 Jan 5, 2017 as substantially equivalent to K103657 (Orbusneich Medical, Inc., 2011) and 2 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1980. 4 later devices descend from it.
- Decided
- Jan 5, 2017
- Review
- 59 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to P790017 (1980). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 2 generations backK103808 Sapphire NCOrbusneich Medical, Inc. · 2011
- 1 generation backK162209 Sapphire NC PlusOrbusneich Medical, Inc. · 2016
- This deviceK163114 Sapphire II PROOrbusneich Medical, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK173680 Sapphire II PROOrbusneich Medical Trading, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK233505 Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK202619 KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK182699 Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K173680Sapphire II PROOrbusneich Medical Trading, Inc. · 2018 · cites it directly1descendant
- K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024 · 2 generations on0descendants
- K202619KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd. · 2021 · cites it directly0descendants
- K182699Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −2 | K103808 | Sapphire NC | Orbusneich Medical, Inc. | 2011 | — |
| −1 | K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | 2016 | — |
| 0 (this device) | K163114 | Sapphire II PRO | Orbusneich Medical, Inc. | 2017 | — |
| +1 | K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018 | — |
| +2 | K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024 | — |
| +1 | K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021 | — |
| +1 | K182699 | Selethru PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K103657 | SapphireSummary page 4…ters, transluminal coronary angioplasty, percutaneous (21 CFR 870.5100(a), Product Code LOX) Predicate Device: Sapphire (K103657; cleared August 9, 2011) Sapphire NC (K103808; cleared September 1, 2011)… | 2011 |
| * | K103808 | Sapphire NCSummary page 4…870.5100(a), Product Code LOX) Predicate Device: Sapphire (K103657; cleared August 9, 2011) Sapphire NC (K103808; cleared September 1, 2011) Sapphire NC Plus (K162209; cleared October 6, 2016) Device Descrip… | 2011 |
| * | K162209 | Sapphire NC PlusSummary page 4…re (K103657; cleared August 9, 2011) Sapphire NC (K103808; cleared September 1, 2011) Sapphire NC Plus (K162209; cleared October 6, 2016) Device Description: The Sapphire II PRO coronary dilatation catheter is a percut aneous… | 2016 |
What descends from it? (4)
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 37 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K173680 (Orbusneich Medical Trading, Inc., 2018) has gone furthest, with 1 descendant of its own.
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. 2017, 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 II PRO 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163114: Sapphire II PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163114
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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