510(k) · Cleared
ClearedSapphire II PRO Balloon Dilatation Catheter
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 Jun 28, 2018 as substantially equivalent to K131199 (Bard Peripheral Vascular, Inc., 2013) after an 80-day review. Its family tree reaches back 4 generations to 2004. 3 later devices descend from it.
- Decided
- Jun 28, 2018
- Review
- 80 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042537 (2004). 7 ancestors in all, the oldest K012913 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 3 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 2 generations backK100490 Litepac, Model 682ClearStream Technologies, Ltd. · 2010
- 1 generation backK131199 Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013
- This deviceK180921 Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK252295 RyureiTerumo Corporation · 2026
- Descendant · cites it directly · 0 of its ownK211349 Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK200269 Sapphire II PROOrbusneich Medical Trading, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −3 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −2 | K100490 | Litepac, Model 682 | ClearStream Technologies, Ltd. | 2010 | — |
| −1 | K131199 | Ultraverse RX Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2013 | — |
| 0 (this device) | K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018 | — |
| +1 | K252295 | Ryurei | Terumo Corporation | 2026 | — |
| +1 | K211349 | Selebrek PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022 | — |
| +1 | K200269 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K131199 | Ultraverse RX Pta Balloon Dilatation CatheterSummary page 4…LOX (primary) LIT (secondary Device Class: Class II Predicate Device: Bard Ultraverse (K131199; LIT; cleared May 30, 2013) Reference Devices: Abbott Armada 14 XT (K121352; LIT; cleared 15-Aug-2012)… | 2013 |
| † | K121352 | Armada 14XXT Pta Catheter | 2012 |
| † | K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | 2016 |
| † | K173894 | Jade PTA Balloon Dilatation Catheter | 2018 |
| † | K173680 | Sapphire II PRO | 2018 |
| † | K163114 | Sapphire II PRO | 2017 |
What descends from it? (3)
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 14 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K252295 (Terumo Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K131199.
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® II PRO balloon 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. The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients…
Read the full statement (114 words)
The Sapphire® II PRO balloon 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.
The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) 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.
The Sapphire® II PRO balloon dilatation catheter is also indicated for:
percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.
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/K180921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180921: Sapphire II PRO Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180921
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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