510(k) · Cleared
ClearedMinjie Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kai Medtech, LLC · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Jun 2, 2022 as substantially equivalent to K150107 (Micro Therapeutics Inc Dba Ev3 Neurovascular, 2015) after a 316-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Jun 2, 2022
- Review
- 316 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K110055 (2011). No later device cites it as a predicate yet.
- Root · 2 generations backK110055 Reverse Medical Reflex Guide CatheterReverse Medical Corporation · 2011
- 1 generation backK150107 Arc Intracranial Support Catheter, Arc Mini Intracranial Support…Micro Therapeutics Inc Dba Ev3 Neurovascular · 2015
- This deviceK212288 Minjie Catheter SystemKai Medtech, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K110055 | Reverse Medical Reflex Guide Catheter | Reverse Medical Corporation | 2011 | — |
| −1 | K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter | Micro Therapeutics Inc Dba Ev3 Neurovascular | 2015 | — |
| 0 (this device) | K212288 | Minjie Catheter System | Kai Medtech, LLC | 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 |
|---|---|---|---|
| * | K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support CatheterSummary page 5…of Device Device Manufacturer Number Code Predicate Device Arc™ Intracranial Support Micro Therapeutics, Inc. K150107 DQY Catheter and Arc™ Mini d/b/a ev3 Neurovascular In… | 2015 |
| † | K161152 | Navien Intracranial Support Catheter | 2016 |
| † | K140080 | Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB… | 2014 |
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 11 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K150107.
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 Minjie Catheter System is indicated for the introduction of interventional devices into the peripheral and
neruovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212288: Minjie Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212288
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