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 4, 2020 as substantially equivalent to K180921 (Orbusneich Medical Trading, Inc., 2018) after a 29-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Mar 4, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042537 (2004). 8 ancestors in all, the oldest K012913 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 4 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 3 generations backK100490 Litepac, Model 682ClearStream Technologies, Ltd. · 2010
- 2 generations backK131199 Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013
- 1 generation backK180921 Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018
- This deviceK200269 Sapphire II PROOrbusneich Medical Trading, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −4 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −3 | K100490 | Litepac, Model 682 | ClearStream Technologies, Ltd. | 2010 | — |
| −2 | K131199 | Ultraverse RX Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2013 | — |
| −1 | K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K180921 | Sapphire II PRO Balloon Dilatation CatheterSummary page 4…lasty (PTCA) Catheter Catheters, transluminal coronary angioplasty, percutaneous 21 CFR 870.5100(a) LOX (primary) LIT (secondary Class II OrbusNeich Sapphire II PRO (K180921; LOX, LIT; cleared 28-Jun- 2018) Abbott Vascular Mini Trek OTW (K110617; LOX; cleared 02-Jun- 2011) Boston Scientific Emerge OTW… | 2018 |
| † | K110617 | Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary… | 2011 |
| † | K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter… | 2013 |
| † | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K180921.
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. 2020, 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 purpose 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 (118 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 purpose 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/K200269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200269: Sapphire II PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200269
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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