510(k) · Cleared

Cleared

Contour SE Microspheres

K034068510(k) TraditionalCleared Mar 26, 200486-day reviewClass II21 CFR 870.3300

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

Boston Scientific Corp · KRD Device, Vascular, For Promoting Embolization

Cleared on Mar 26, 2004 as substantially equivalent to K022427 (Boston Scientific Corp, 2002) and 3 other predicates after an 86-day review. Its family tree reaches back 5 generations to 1996. 10 later devices descend from it.

Decided: Mar 26, 2004
Review: 86 days
Class: Class II
Product code: KRD
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K961923 (1996). 11 ancestors in all, the oldest K871047 (1987). 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
4 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
3 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
2 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
1 generation backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
This deviceK034068 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
Descendant · 2 generations on · 1 of its ownK141209 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 3 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all

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
K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc. · 2014 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K961923	Berenstein Coil	Target Therapeutics	1996	—
−4	K964112	Berenstein Coil	Target Therapeutics	1997	—
−3	K991549	Embosphere Microspheres	Biosphere Medical	2000	—
−2	K021397	Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid…	Biosphere Medical, Inc.	2002	—
−1	K030966	Contour Emboli Pva and Fastracker-325 Infusion Catheter	Boston Scientific Corp	2003	1
0 (this device)	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	—
+2	K141209	Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…	Celonova Biosciences, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1994	1	0
2001	1	0
2002	1	0
2003	2	0

Descendants by year cleared

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

FIG. 1 — Lineage of K034068, 1996–2024Source: 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 KRD? 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 KRD device

#1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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? (4)

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
*	K022427	Contour SE Microspheres Summary page 1 …me: Contour SETM Microspheres Provisions Classification Name: Artificial Embolization Device Name of Contour SETM Microspheres (K022427, K032707 & K032542) Predicate Contour TM Emboli PVA (K030966) Devices Classification Class III Perform…	Boston Scientific Corp	2002	—
*	K032707	Contour SE Microspheres (Syringe) Summary page 1 …ur SETM Microspheres Provisions Classification Name: Artificial Embolization Device Name of Contour SETM Microspheres (K022427, K032707 & K032542) Predicate Contour TM Emboli PVA (K030966) Devices Classification Class III Performance…	Boston Scientific Corp	2003	—
*	K032542	Modification to Contour SE Microspheres Summary page 1 …crospheres Provisions Classification Name: Artificial Embolization Device Name of Contour SETM Microspheres (K022427, K032707 & K032542) Predicate Contour TM Emboli PVA (K030966) Devices Classification Class III Performance Pe…	Boston Scientific Corp	2003	—
*	K030966	Contour Emboli Pva and Fastracker-325 Infusion Catheter Summary page 1 …tion Name: Artificial Embolization Device Name of Contour SETM Microspheres (K022427, K032707 & K032542) Predicate Contour TM Emboli PVA (K030966) Devices Classification Class III Performance Performance Standards have not been established by FDA und…	Boston Scientific Corp	2003	1

Also cleared against K022427: 1 other device →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K073417	Embozene Microspheres	Celonova Biosciences, Inc.	2008	6
K061790	Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles	Protein Polymer Technologies, Inc.	2006	1
K081768	Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles	Cook Incorporated	2008	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?

The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 10 months on median.
1 of the 11 ancestors has a recall of any class.
Of its descendants, K073417 (Celonova Biosciences, Inc., 2008) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K022427.

How does its category compare?

All KRD devices

KRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRD

9in 2025

2007high 11 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRD

60in 2025

2007high 178 (2019) · low 27 (2009)2026

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

Recalls per year · KRD

1in 2024

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KRD

1,572in 2025

2007high 1,572 (2025) · low 14 (2008)2025

MAUDE reports naming product code KRD, 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	2	—	0	21
2008	5	84	0	14
2009	4	27	0	40
2010	3	150	1	61
2011	5	36	0	102
2012	8	30	0	137
2013	11	33	1	244
2014	7	134	0	159
2015	11	130	0	337
2016	4	164	0	437
2017	4	89	0	736
2018	4	62	0	1,066
2019	6	178	0	1,185
2020	4	137	0	1,167
2021	3	134	0	1,444
2022	8	175	0	1,498
2023	2	—	1	1,371
2024	6	70	1	1,535
2025	9	60	0	1,572
2026	7	70	1	—

What is it indicated for?

Contour SETM Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K034068 · printed Nov 5, 2026

Cite this page

510(k) Report. “K034068: Contour SE Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034068

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