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 Trading, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Mar 1, 2018 as substantially equivalent to K163114 (Orbusneich Medical, Inc., 2017) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it.
- Decided
- Mar 1, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to P860019 (1986). 13 ancestors in all, the oldest P790017 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 3 generations backK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
- 2 generations backK121196 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corp · 2012 · Recalled
- 1 generation backK130391 Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca…Boston Scientific Corp · 2013 · Recalled
- This deviceK173680 Sapphire II PROOrbusneich Medical Trading, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK233505 Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −3 | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corporation | 2012 | 1 |
| −2 | K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corp | 2012 | 1 |
| −1 | K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation… | Boston Scientific Corp | 2013 | 1 |
| 0 (this device) | K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018 | — |
| +1 | K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K163114 | Sapphire II PROSummary page 4…ransluminal coronary angioplasty, percutaneous (21 CFR 870.5100(a), Product Code LOX) Predicate Device: Sapphire II PRO (K163114; cleared January 5, 2017) Mini Trek (K110617; cleared June 2, 2011)… | 2017 |
| * | K110617 | Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary…Summary page 4…870.5100(a), Product Code LOX) Predicate Device: Sapphire II PRO (K163114; cleared January 5, 2017) Mini Trek (K110617; cleared June 2, 2011) Emerge (K130391; cleared July 10, 2013)… | 2011 |
| * | K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…Summary page 4…Sapphire II PRO (K163114; cleared January 5, 2017) Mini Trek (K110617; cleared June 2, 2011) Emerge (K130391; cleared July 10, 2013) Sprinter Legend (K103095; cleared October 22, 2010) Device Description… | 2013 |
| * | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonSummary page 4…Mini Trek (K110617; cleared June 2, 2011) Emerge (K130391; cleared July 10, 2013) Sprinter Legend (K103095; cleared October 22, 2010) Device Description: The 1.0-1.25mm Sapphire II PRO coronary dilatation catheter is a… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | 2024 | 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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K233505 (OrbusNeich Medical (Shenzhen) Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K163114.
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. 2018, 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 Il PRO coronary dilatation catheter (1.0-1.25mm configurations) is indicated for:
* balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (>70% stenosis) for the purposes of improving myocardial perfusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173680: 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/K173680
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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