510(k) · Cleared

Cleared

Occlusion Balloon

K062202510(k) SpecialCleared Oct 20, 200680-day reviewClass II21 CFR 870.1250

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

Boston Scientific Corp · DQY Catheter, Percutaneous

Cleared on Oct 20, 2006 after an 80-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Oct 20, 2006
Review: 80 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK062202 Occlusion BalloonBoston Scientific Corp · 2006
Descendant · cites it directly · 1 of its ownK132990 Occlusion Balloon CatheterBoston Scientific Corp · 2013
Descendant · 2 generations on · 0 of its ownK143613 PaxWire Occlusion Balloon SystemAccessclosure, Inc. · 2015 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K132990Occlusion Balloon CatheterBoston Scientific Corp · 2013 · cites it directly1descendant
K143613PaxWire Occlusion Balloon SystemAccessclosure, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K062202	Occlusion Balloon	Boston Scientific Corp	2006	—
+1	K132990	Occlusion Balloon Catheter	Boston Scientific Corp	2013	—
+2	K143613	PaxWire Occlusion Balloon System	Accessclosure, Inc.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0

FIG. 1 — Lineage of K062202, 2006–2015Source: 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 DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (2)

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
*	—	Occlusion Balloon Catheter Named without a submission number			—
*	—	Van-Tec Occlusion Balloon Catheter Named without a submission number			—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132990	Occlusion Balloon Catheter	Boston Scientific Corp	2013	1

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, K132990 (Boston Scientific Corp, 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

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

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.

The Occlusion Balloon Catheter product line consists of two specific designs - Standard Occlusion Balloons and BerensteinTM Occlusion Balloon Catheters.

Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062202: Occlusion Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062202

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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