510(k) · Cleared

Recalled · Class II · 2020

Opticross 35 15 MHz Peripheral Imaging Catheter

K200733510(k) SpecialCleared Apr 17, 202028-day reviewClass II21 CFR 892.1570Recalls 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 · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Apr 17, 2020 as substantially equivalent to K080272 (Boston Scientific Corp, 2008) after a 28-day review. Its family tree reaches back 2 generations to 2005. It has been recalled once.

Decided: Apr 17, 2020
Review: 28 days
Class: Class II
Product code: ITX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K050684 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK050684 Atlantis PVBoston Scientific Corp · 2005
1 generation backK080272 Atlantis Pvimaging Catheter, Model H749364560Boston Scientific Corp · 2008 · Recalled
This deviceK200733 Opticross 35 15 MHz Peripheral Imaging CatheterBoston Scientific Corporation · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K050684	Atlantis PV	Boston Scientific Corp	2005	—
−1	K080272	Atlantis Pvimaging Catheter, Model H749364560	Boston Scientific Corp	2008	2
0 (this device)	K200733	Opticross 35 15 MHz Peripheral Imaging Catheter	Boston Scientific Corporation	2020	—

FIG. 1 — Lineage of K200733, 2005–2020Source: 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 ITX? 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 ITX device

#1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K080272	Atlantis Pvimaging Catheter, Model H749364560 Summary page 4 …FR 892.1570 – Transducer, Ultrasonic, Diagnostic 21 CFR 870.1200 – Catheter, Ultrasound Intravascular Predicate Device Atlantis PV Imaging Catheter (K080272), cleared March 11, 2008 Reference Device OptiCross 18 30 MHz Peripheral Imaging Catheter (K160514), cleared…	Boston Scientific Corp	2008	2
†	K160514	OptiCross 18, 30 MHz Peripheral Imaging Catheter	Boston Scientific Corporation	2016	—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 24, 2020	Class II	Z-0181-2021	Process control	Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · ITX

4in 2025

2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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	10	26	0	16
2008	12	73	4	39
2009	17	28	4	23
2010	10	42	4	30
2011	10	16	1	34
2012	7	25	1	29
2013	3	105	0	38
2014	4	41	1	43
2015	1	—	5	183
2016	4	151	0	269
2017	6	110	1	412
2018	2	—	15	130
2019	1	—	0	119
2020	3	120	3	116
2021	3	139	10 (10)	146
2022	2	—	6	87
2023	6	213	1	138
2024	3	81	1	988
2025	4	126	2	571
2026	6	158	0	—

What is it indicated for?

The OptiCross 35 15 MHz Peripheral Imaging Catheter is intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200733 · printed Nov 3, 2026

Cite this page

510(k) Report. “K200733: Opticross 35 15 MHz Peripheral Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200733

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