510(k) · Cleared

Recalled · Class II · 2019

Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)

K113220510(k) TraditionalCleared Mar 22, 2012142-day reviewClass II21 CFR 870.5100Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corporation · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cleared on Mar 22, 2012 as substantially equivalent to P860019 (Scimed Life Systems, Inc., 1986) after a 142-day review. Its family tree reaches back 1 generation to 1986. 15 later devices descend from it. It has been recalled once.

Decided: Mar 22, 2012
Review: 142 days
Class: Class II
Product code: LOX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to P860019 (1986). 15 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
This deviceK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012
Descendant · cites it directly · 8 of its ownK121196 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corp · 2012 · Recalled
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 · 3 of its ownK141236 NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca…Boston Scientific Corporation · 2014 · 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

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 15 · See all

K121196Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Boston Scientific Corp · 2012 · cites it directly8descendants
K130391Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…Boston Scientific Corp · 2013 · cites it directly7descendants
K141236NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter…Boston Scientific Corporation · 2014 · cites it directly3descendants
K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 2016 · cites it directly2descendants
K173680Sapphire II PROOrbusneich Medical Trading, Inc. · 2018 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P860019	Scimed Ptca Dilatation Catheter	Scimed Life Systems, Inc.	1986	5
0 (this device)	K113220	Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter…	Boston Scientific Corporation	2012	—
+1	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
+1	K141236	NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation…	Boston Scientific Corporation	2014	1
+1	K163174	Emerge PTCA Dilatation Catheter	Boston Scientific Corporation	2016	1
+2	K173680	Sapphire II PRO	Orbusneich Medical Trading, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2014	2	0
2016	1	0
2017	2	0
2018	1	0
2020	1	0
2021	1	0
2022	2	0
2023	2	0
2024	1	0

FIG. 1 — Lineage of K113220, 1986–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	P860019	Scimed Ptca Dilatation Catheter Summary page 1 …(PTCA) Dilatation Catheter Product Code LOX Classification Class 11, 21 CFR Part 870.5100 Predicate Apex TM PTCA Dilatation Catheter P860019 07 November 2008 Devices /S208 2…	Scimed Life Systems, Inc.	1986	5

Also cleared against P860019: 20 other devices →

What descends from it? (15)

See all 15

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121196	Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)	Boston Scientific Corp	2012	8
K130391	Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…	Boston Scientific Corp	2013	7
K141236	NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter…	Boston Scientific Corporation	2014	3
K163174	Emerge PTCA Dilatation Catheter	Boston Scientific Corporation	2016	2
K162253	Trapper Exchange Device	Creganna Medical Aslo Business AS Cregganna Tactx Medical	2017	1
K162625	SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters	B. Braun Interventional Systems, Inc.	2017	0

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?

Its one ancestor has a recall.
Of its descendants, K121196 (Boston Scientific Corp, 2012) has gone furthest, with 8 descendants of its own.
20 other devices also cite its predicate P860019.

How does its category compare?

All LOX devices

LOX 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

2007high 32 (2010) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOX

241in 2024

2007high 241 (2024) · low 80 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LOX

4in 2019

2007high 80 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOX

1,890in 2025

2007high 2,753 (2017) · low 1,053 (2007)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 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/K113220 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113220: 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/K113220

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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