510(k) · Cleared
Recalled · Class II · 2019Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Jul 10, 2013 as substantially equivalent to K113220 (Boston Scientific Corporation, 2012) and 1 other predicate after a 145-day review. Its family tree reaches back 3 generations to 1986. 7 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2013
- Review
- 145 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to P860019 (1986). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 2 generations backK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
- 1 generation backK121196 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corp · 2012 · Recalled
- This deviceK130391 Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca…Boston Scientific Corp · 2013
- Descendant · cites it directly · 2 of its ownK163174 Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 2016 · Recalled
- 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 · 2 generations on · 0 of its ownK223022 SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK220629 Emerge Monorail PTCA Dilatation CatheterBoston Scientific · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 2016 · cites it directly2descendants
- K173680Sapphire II PROOrbusneich Medical Trading, Inc. · 2018 · cites it directly1descendant
- K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024 · 2 generations on0descendants
- K223022SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2023 · 2 generations on0descendants
- K220629Emerge Monorail PTCA Dilatation CatheterBoston Scientific · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −2 | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corporation | 2012 | 1 |
| −1 | K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corp | 2012 | 1 |
| 0 (this device) | K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation… | Boston Scientific Corp | 2013 | — |
| +1 | K163174 | Emerge PTCA Dilatation Catheter | Boston Scientific Corporation | 2016 | 1 |
| +1 | K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018 | — |
| +2 | K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024 | — |
| +2 | K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2023 | — |
| +2 | K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Summary page 1…on Catheter Product Code LOX Classification Class 11,21 CFR Part 870.5100 Predicate Emerge T M PTCA Dilatation K1 13220 March 22, 2012 Devices Catheter (2.00 - 4.00 mm diameter balloon models)… | 2012 |
| * | K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Summary page 1…March 22, 2012 Devices Catheter (2.00 - 4.00 mm diameter balloon models) Emerge TM PTCA Dilatation K121196 August 31, 2012 Catheter (1.50 mm diameter balloon models) Device The B… | 2012 |
What descends from it? (7)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2019 | Class II | Z-0577-2020 | Process control | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K163174 (Boston Scientific Corporation, 2016) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K113220.
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. 2013, 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 Emerge Over-The-Wire and Emerge Monorail PTCA Dilastation Catheters (1.20 mm balloon models) are Indicated as pro-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (70% stenosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130391: Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130391
Report an extraction error
Are you the manufacturer?
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