510(k) · Cleared
Recalled · Class II · 2019Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)
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 Aug 31, 2012 as substantially equivalent to K113220 (Boston Scientific Corporation, 2012) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 1986. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 31, 2012
- Review
- 134 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to P860019 (1986). 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 1 generation backK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
- This deviceK121196 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corp · 2012
- Descendant · cites it directly · 7 of its ownK130391 Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca…Boston Scientific Corp · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK163174 Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK173680 Sapphire II PROOrbusneich Medical Trading, Inc. · 2018
- Descendant · 3 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130391Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…Boston Scientific Corp · 2013 · cites it directly7descendants
- K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 2016 · cites it directly2descendants
- K173680Sapphire II PROOrbusneich Medical Trading, Inc. · 2018 · 2 generations on1descendant
- K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024 · 3 generations on0descendants
- K223022SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −1 | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corporation | 2012 | 1 |
| 0 (this device) | K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corp | 2012 | — |
| +1 | K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation… | Boston Scientific Corp | 2013 | 1 |
| +1 | K163174 | Emerge PTCA Dilatation Catheter | Boston Scientific Corporation | 2016 | 1 |
| +2 | K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018 | — |
| +3 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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…Dilatation Catheter Product Code LOX Classification Class 11, 21 CFR Part 870.5100 Predicate Emerge"" PTCA Dilatation K113220 .22 March 2012 Devices Catheter Apex'TM PTCA Dilatation Catheter P860019 07 November… | 2012 |
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 1…edicate Emerge"" PTCA Dilatation K113220 .22 March 2012 Devices Catheter Apex'TM PTCA Dilatation Catheter P860019 07 November 2008 /S208 Device The Boston Scientifi… | 1986 |
What descends from it? (8)
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)
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 26 years and passes through 3 companies; a new generation was cleared every 25.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K130391 (Boston Scientific Corp, 2013) has gone furthest, with 7 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. 2012, 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 Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents; (bare metal and drug-eluting).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121196: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121196
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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