510(k) · Cleared

Cleared

Contour SE Microspheres (Syringe)

K032707510(k) SpecialCleared Sep 23, 200321-day reviewClass II21 CFR 882.5950

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

Boston Scientific Corp · HCG Device, Neurovascular Embolization

Cleared on Sep 23, 2003 after a 21-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided: Sep 23, 2003
Review: 21 days
Class: Class II
Product code: HCG
Recalls: None
Predicates: 0

12 later devices descend from it, 3 citing it directly.

This deviceK032707 Contour SE Microspheres (Syringe)Boston Scientific Corp · 2003
Descendant · cites it directly · 10 of its ownK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
Descendant · cites it directly · 6 of its ownK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
Descendant · 2 generations on · 4 of its ownK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
Descendant · 2 generations on · 2 of its ownK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
Descendant · 2 generations on · 2 of its ownK130307 Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML…Celonova Biosciences, Inc. · 2013

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004high 3 (2008) · low 0 (2005)2026

Most influential descendants

Showing 5 of 12 · See all

K034068Contour SE MicrospheresBoston Scientific Corp · 2004 · cites it directly10descendants
K073417Embozene MicrospheresCelonova Biosciences, Inc. · 2008 · cites it directly6descendants
K132675Embozene MicrospheresCelonova Biosciences, Inc. · 2013 · 2 generations on4descendants
K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc. · 2014 · 2 generations on2descendants
K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc. · 2013 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032707	Contour SE Microspheres (Syringe)	Boston Scientific Corp	2003	—
+1	K034068	Contour SE Microspheres	Boston Scientific Corp	2004	—
+1	K073417	Embozene Microspheres	Celonova Biosciences, Inc.	2008	—
+2	K132675	Embozene Microspheres	Celonova Biosciences, Inc.	2013	—
+2	K133447	Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres	Celonova Biosciences, Inc.	2014	—
+2	K130307	Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene…	Celonova Biosciences, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	2	0
2008	3	0
2013	2	0
2014	2	0
2016	1	0
2024	1	0

FIG. 1 — Lineage of K032707, 2003–2024Source: 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 HCG? 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 HCG device

#1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 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? (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	Recalls
*	—	Contour Emboli PVA Named without a submission number	—
*	—	Embosphere Microspheres Named without a submission number	—
*	—	EmboGold Microspheres Named without a submission number	—

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K034068	Contour SE Microspheres	Boston Scientific Corp	2004	10
K073417	Embozene Microspheres	Celonova Biosciences, Inc.	2008	6
K052509	M-Bolus Embolic Microspheres	Scion Cardio-Vascular, Inc.	2006	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K034068 (Boston Scientific Corp, 2004) has gone furthest, with 10 descendants of its own.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCG

3in 2025

2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007high 173 (2018) · low 30 (2012)2026

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

Recalls per year · HCG

1in 2025

2007high 4 (2014) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HCG

537in 2025

2007high 2,494 (2017) · low 326 (2007)2025

MAUDE reports naming product code HCG, 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	8	50	1	326
2008	9	71	3	730
2009	7	48	0	821
2010	8	72	2	851
2011	9	78	1	894
2012	7	30	0	1,146
2013	7	67	2	1,103
2014	5	66	4	1,729
2015	5	60	0	1,598
2016	7	37	0	1,991
2017	5	97	0	2,494
2018	4	173	0	2,058
2019	1	—	0	1,763
2020	2	—	0	1,754
2021	5	103	0	2,268
2022	3	114	2	663
2023	2	—	0	568
2024	4	49	1	552
2025	3	107	1 (1)	537
2026	4	30	1	—

What is it indicated for?

Contour SET™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032707 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032707: Contour SE Microspheres (Syringe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032707

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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