510(k) · Cleared
ClearedOcclusion Balloon Catheter Model Obc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 6, 2010 as substantially equivalent to K032869 (Cook, Inc., 2003) after a 31-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Aug 6, 2010
- Review
- 31 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003495 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −1 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| 0 (this device) | K101877 | Occlusion Balloon Catheter Model Obc | Cook, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 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
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 |
|---|---|---|---|
| * | K032869 | Cook Coda Balloon CatheterSummary page 1…f intended use, method of operation, materials of construction, and technological characteristics to the predicate device which was cleared as the CODA Balloon Catheter (K032869). Device Description: The Occlusion Balloon Catheter is a triple lumen balloon catheter designed to temporarily occlude large v… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- 8 other devices also cite its predicate K032869.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 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?
The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101877: Occlusion Balloon Catheter Model Obc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101877
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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