510(k) · Cleared
ClearedBalloon Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Heartcare Medical Technology Co., Ltd. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Aug 25, 2021 as substantially equivalent to K122581 (Concentric Medical, Inc., 2012) after a 330-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Aug 25, 2021
- Review
- 330 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010954 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 4 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 3 generations backK102657 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
- 2 generations backK112404 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012 · Recalled
- 1 generation backK122581 Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · Recalled
- This deviceK202916 Balloon Guiding CatheterShanghai Heartcare Medical Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −4 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −3 | K102657 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2010 | — |
| −2 | K112404 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2012 | 1 |
| −1 | K122581 | Modified Balloon Guide Catheter Model 90253, 90254 | Concentric Medical, Inc. | 2012 | 1 |
| 0 (this device) | K202916 | Balloon Guiding Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2021 | — |
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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 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 |
|---|---|---|---|
| * | K122581 | Modified Balloon Guide Catheter Model 90253, 90254Summary page 5…ffective lengths, the difference between S type and S+ type is the size of the catheter. 5. Identification of Predicate Device [807.92(a)(3)] 510(k) Number: K122581 Product Name: Modified Balloon Guide Catheter… | 2012 |
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 20 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K122581.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202916: Balloon Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202916
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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