510(k) · Cleared
Recalled · Class II · 2019Emerge PTCA Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Dec 14, 2016 as substantially equivalent to K113220 (Boston Scientific Corporation, 2012) and 2 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 14, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to P860019 (1986). 2 later devices descend from it, 2 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 deviceK163174 Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 2016
- Descendant · cites it directly · 0 of its ownK223022 SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK220629 Emerge Monorail PTCA Dilatation CatheterBoston Scientific · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K163174 | Emerge PTCA Dilatation Catheter | Boston Scientific Corporation | 2016 | — |
| +1 | K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2023 | — |
| +1 | K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 6…== Page 6 === K163174 Predicate Devices EmergeTM PTCA Dilatation Catheter, K113220, cleared 22 March 2012. EmergeTM PTCA Dilatation Catheter, K121196, cleared 3… | 2012 |
| * | K121196 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Summary page 6…Devices EmergeTM PTCA Dilatation Catheter, K113220, cleared 22 March 2012. EmergeTM PTCA Dilatation Catheter, K121196, cleared 31 August 2012. EmergeTM PTCA Dilatation Catheter, K130391, cleared… | 2012 |
| * | K130391 | Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…Summary page 6…EmergeTM PTCA Dilatation Catheter, K121196, cleared 31 August 2012. EmergeTM PTCA Dilatation Catheter, K130391, cleared 10 July 2013. Reference NC Emerge™ PTCA Dilatation Catheter, K141236, Device… | 2013 |
| † | K141236 | NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter… | 2014 |
What descends from it? (2)
2 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 30 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K223022 (Sino Medical Sciences Technology, Inc., 2023) has gone furthest, with 0 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. 2016, 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 (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis). The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the…
Read the full statement (99 words)
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) 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.
The 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/K163174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163174: Emerge PTCA Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163174
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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