510(k) · Cleared
ClearedMicro 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 Feb 10, 2022 as substantially equivalent to K192122 (Stryker, 2019) after a 499-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Feb 10, 2022
- Review
- 499 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003086 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK003086 Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc. · 2001
- 4 generations backK091961 Modified Concentric Microcatheter, Model 90047Concentric Medical, Inc. · 2009
- 3 generations backK111619 Modified Concentric MicrocatheterConcentric Medical, Inc. · 2011
- 2 generations backK113260 Modified Concentirc MicrocatheterConcentric Medical, Inc. · 2012 · Recalled
- 1 generation backK192122 Trevo Trak 21 MicrocatheterStryker · 2019 · Recalled
- This deviceK202926 Micro CatheterShanghai Heartcare Medical Technology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003086 | Concentric Micro Catheter, Models 90001 to 90008 | Concentric Medical, Inc. | 2001 | — |
| −4 | K091961 | Modified Concentric Microcatheter, Model 90047 | Concentric Medical, Inc. | 2009 | — |
| −3 | K111619 | Modified Concentric Microcatheter | Concentric Medical, Inc. | 2011 | — |
| −2 | K113260 | Modified Concentirc Microcatheter | Concentric Medical, Inc. | 2012 | 5 |
| −1 | K192122 | Trevo Trak 21 Microcatheter | Stryker | 2019 | 1 |
| 0 (this device) | K202926 | Micro Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K192122 | Trevo Trak 21 MicrocatheterSummary page 5…ber: 21CFR 870.1250 Review Panel: Cardiovascular 4. Identification of Predicate Device and Reference Devices Predicate Device 510(k) Number: K192122 Product Name: Trevo Trak 21 Microcatheter Reference Device 1 510(k) Number: K993672 Product Name: Re… | 2019 |
| † | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | 2000 |
| † | K001966 | Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and… | 2000 |
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 21 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K192122.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Micro Catheter is intended for selective delivery of therapeutic devices and infusion of contrast media into the peripheral and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202926: Micro Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202926
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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