510(k) · Cleared
ClearedOlympus B5-2C/B7-2C Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Aug 20, 1996 as substantially equivalent to K904669 (Olympus Corp., 1991) after a 26-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Aug 20, 1996
- Review
- 26 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904669 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904669 Balloon CathetersOlympus Corp. · 1991
- This deviceK962901 Olympus B5-2C/B7-2C Balloon CatheterOlympus America, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK250118 Disposable Balloon Catheter B5-2COlympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK171492 B7 2C Occlusion BalloonSpiration, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904669 | Balloon Catheters | Olympus Corp. | 1991 | — |
| 0 (this device) | K962901 | Olympus B5-2C/B7-2C Balloon Catheter | Olympus America, Inc. | 1996 | — |
| +1 | K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K171492 | B7 2C Occlusion Balloon | Spiration, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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 EOQ? 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 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 |
|---|---|---|---|
| * | K904669 | Balloon CathetersSummary page 1…Balloon Catheters Common/Usual Name: Balloon Catheter Classification Name: Bronchoscope and Accessories Predicate Devices: Olympus B5-2C/B7-2C Biliary Balloon Catheter (K904669) Submitted By: Mr. Barry Sands (Contact Person) - Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, N… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
Olympus B5-2C/B7-2C Balloon Catheters are to be used for selective endoscopic bronchography,
medicine injection to bronchi, saline injection associated with bronchoalveoler lavage, foreign body
removal from bronchi, and bronchial hemostasis (tamponade).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962901: Olympus B5-2C/B7-2C Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962901
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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