510(k) · Cleared
ClearedOccluder Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Jan 8, 2014 as substantially equivalent to K841941 (Van-Tec, Inc., 1984) after a 30-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.
- Decided
- Jan 8, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K841941 (1984). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K183323UPJ Occlusion Balloon CatheterCook Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841941 | Van-Tec Occlusion Balloon Catheter | Van-Tec, Inc. | 1984 | — |
| 0 (this device) | K133750 | Occluder Occlusion Balloon Catheter | Boston Scientific Corporation | 2014 | — |
| +1 | K183323 | UPJ Occlusion Balloon Catheter | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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 EYB? 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 EYB device
- #1 K192183 RocaTub Ureteral Catheterscore -0.2 · 3 generations · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K841941 | Van-Tec Occlusion Balloon CatheterSummary page 1…ogical Classification Name: KOD - Catheter, Urological Prernarket Notification: Van-Tec Occlusion Balloon Catheter (Submitted by Van- Tec, Inc.), K841941 /A, August 8, 1984. E. Device IDescription OcelUder Occlusion Balloon Catheters are designed for use for temporary O… | 1984 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183323 | UPJ Occlusion Balloon Catheter | 2019 | 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?
- Its one ancestor has no recall.
- Of its descendants, K183323 (Cook Incorporated, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EYB
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EYB
248in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EYB
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EYB
11in 2025
MAUDE reports naming product code EYB, 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 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 1 | 15 |
| 2009 | 1 | — | 0 | 42 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 3 | 248 | 0 | 22 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Occluder Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133750 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133750: Occluder Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133750
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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