510(k) · Cleared
ClearedCello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fuji Systems Corp. · DQY Catheter, Percutaneous
Cleared on Aug 9, 2012 as substantially equivalent to K021899 (Concentric Medical, Inc., 2002) after a 147-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Aug 9, 2012
- Review
- 147 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010954 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 1 generation backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- This deviceK120781 Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM LengthFuji Systems Corp. · 2012
- Descendant · cites it directly · 2 of its ownK203723 Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK221951 Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK251240 Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK223275 CELLO II Balloon Guide CatheterFuji Systems Corporation · 2022
Most influential descendants
Showing 4 of 4 · See all- K203723Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2021 · cites it directly2descendants
- K221951Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2022 · 2 generations on1descendant
- K251240Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2025 · 3 generations on0descendants
- K223275CELLO II Balloon Guide CatheterFuji Systems Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −1 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| 0 (this device) | K120781 | Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length | Fuji Systems Corp. | 2012 | — |
| +1 | K203723 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2021 | — |
| +2 | K221951 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2022 | — |
| +3 | K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2025 | — |
| +1 | K223275 | CELLO II Balloon Guide Catheter | Fuji Systems Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 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 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 |
|---|---|---|---|
| * | K021899 | Concentric Balloon Guide Catheter, Model 90072Summary page 1…1610580 (8 F) 1610590 (9F)] Predicate Device Concentric Balloon Guide Catheter, K021899 5 Device Description The CELLO Balloon Guide Catheter is… | 2002 |
What descends from it? (4)
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K203723 (Asahi Intecc Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K021899.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120781: Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120781
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