510(k) · Cleared
ClearedMicro Catheter and Guidewire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Hengrui Hongyuan Medical Co., Ltd. · KRA Catheter, Continuous Flush
Cleared on Apr 11, 2022 as substantially equivalent to K171665 (Suzhou Hengrui Disheng Medical Co., Ltd., 2018) after a 227-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Apr 11, 2022
- Review
- 227 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K961923 (1996). 13 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 6 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 5 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 4 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 3 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 2 generations backK033913 ProgreatTerumo Medical Corp. · 2004
- 1 generation backK171665 Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd. · 2018
- This deviceK212719 Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −6 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −5 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −4 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −3 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −2 | K033913 | Progreat | Terumo Medical Corp. | 2004 | — |
| −1 | K171665 | Microcatheter and guide-wire system | Suzhou Hengrui Disheng Medical Co., Ltd. | 2018 | — |
| 0 (this device) | K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 9 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 |
|---|---|---|---|
| * | K171665 | Microcatheter and guide-wire systemSummary page 4…ire System Common or Usual Continuous flush catheter Name: Classification: Class II, 21 CFR Part 870.1210 Product Code: KRA Predicate Device: K171665- Micro Catheter and Guidewire System (Suzhou Hengrui Disheng Medical Co., Ltd) Reference Devices: K03391… | 2018 |
| † | K033913 | Progreat | 2004 |
| † | K172081 | Maestro Microcatheter | 2017 |
| † | K080863 | Traxcess 0.014 Hydrophilic Guidewire | 2008 |
| † | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | 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 26 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vessels. The Micro Catheter and Guidewire system is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The system should not be used in cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212719 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212719: Micro Catheter and Guidewire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212719
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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