510(k) Report

510(k) · Cleared

Recalled · 2011

Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and 38942

K063312510(k) SpecialCleared Nov 30, 200628-day reviewClass II21 CFR 870.1200Recalls 2

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

Boston Scientific Corp · DQO Catheter, Intravascular, Diagnostic

Cleared on Nov 30, 2006 as substantially equivalent to K050577 (Boston Scientific Corp, 2005) after a 28-day review. Its family tree reaches back 1 generation to 2005. 13 later devices descend from it. It has been recalled 2 times.

Decided
Nov 30, 2006
Review
28 days
Class
Class II
Product code
DQO
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K050577 (2005). 13 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2008: 1 descendant cleared2016: 3 descendants cleared2013: 1 descendant cleared2025: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK050577 · Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 · Boston Scientific Corp · 2005 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K050577 · Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 · Boston Scientific Corp · 2005 · recalled0+5
  1. Root · 1 generation backK050577 Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp · 2005 · Recalled
  2. This deviceK063312 Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging…Boston Scientific Corp · 2006
  3. Descendant · cites it directly · 9 of its ownK111043 Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging…Boston Scientific Corp · 2011
  4. Descendant · 2 generations on · 8 of its ownK123621 Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · Recalled
  5. Descendant · 3 generations on · 5 of its ownK153617 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution)…Boston Scientific Corporation · 2016
  6. Descendant · 4 generations on · 3 of its ownK173820 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2018
  7. Descendant · 3 generations on · 3 of its ownK173284 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2017

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12013: 12016: 32017: 12018: 12022: 22023: 12025: 12026: 1
2008high 3 (2016) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all
  • K111043Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterBoston Scientific Corp · 2011 · cites it directly9descendants
  • K123621Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · 2 generations on8descendants
  • K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…Boston Scientific Corporation · 2016 · 3 generations on5descendants
  • K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…Boston Scientific Corporation · 2018 · 4 generations on3descendants
  • K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz…Boston Scientific Corporation · 2017 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K050577Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp20052
0 (this device)K063312Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model…Boston Scientific Corp2006—
+1K111043Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterBoston Scientific Corp2011—
+2K123621Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp20131
+3K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6…Boston Scientific Corporation2016—
+4K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD…Boston Scientific Corporation2018—
+3K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60…Boston Scientific Corporation2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201310
201630
201710
201810
202220
202310
202510
202610
FIG. 1 — Lineage of K063312, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K050577Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014
Summary page 1
…evice(s): Predicate 510(k) Clearance Date Atlantis'Tm SR Pro 2 K(050577 March 30, 2005 Coronary Imaging Catheter (submissio…
Boston Scientific Corp20052

Also cleared against K050577: 3 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K111043Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterBoston Scientific Corp20119
K073623Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp20082

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 28, 2011Not classifiedZ-2418-2011Process designCatheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have…
Mar 28, 2011Not classifiedZ-2419-2011Process designCatheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K111043 (Boston Scientific Corp, 2011) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K050577.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

The Atlantis TM SR Pro 2 Coronary Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Indications for use as stated in the FDA summary.

Also cleared against K050577

3 other devices cite the same predicate.

  • K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc. · 2010
  • K072932Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc. · 2008
  • K060175Isight Imaging Catheter, Model 38986Boston Scientific Corp · 2006

More from Boston Scientific Corp

4,014 FDA decisions under this applicant name. See the company

  • P900056/S229ROTAPRO™ Rotational Atherectomy SystemBoston Scientific Corp · 2026
  • P900056/S226ROTAPRO™ Rotational Atherectomy SystemsBoston Scientific Corp · 2026
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  • P150031/S100Vercise DBS SystemsBoston Scientific Corp · 2026
  • N970003/S311ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2…Boston Scientific Corp · 2026

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K063312 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063312: Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and 38942.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063312

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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