510(k) · Cleared
ClearedClariVein IC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · KRA Catheter, Continuous Flush
Cleared on Aug 6, 2020 as substantially equivalent to K153502 (Vascular Insights, LLC, 2016) after a 28-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 6, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904788 (1990). 11 ancestors in all, the oldest K882796 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 5 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 4 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 3 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 2 generations backK071468 Clarivein CatheterVascular Insights, LLC · 2008 · Recalled
- 1 generation backK153502 ClariVein ICVascular Insights, LLC · 2016
- This deviceK201907 ClariVein ICMerit Medical Systems, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK250794 InVera Infusion DeviceInvera Medical · 2026
- Descendant · cites it directly · 0 of its ownK231148 ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical, Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −5 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −4 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −3 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −2 | K071468 | Clarivein Catheter | Vascular Insights, LLC | 2008 | 1 |
| −1 | K153502 | ClariVein IC | Vascular Insights, LLC | 2016 | — |
| 0 (this device) | K201907 | ClariVein IC | Merit Medical Systems, Inc. | 2020 | — |
| +1 | K250794 | InVera Infusion Device | Invera Medical | 2026 | — |
| +1 | K231148 | ScleroSafe™ 150 mm, ScleroSafe™ 350 mm | Vvt Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 14.4 · 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 |
|---|---|---|---|
| * | K153502 | ClariVein ICSummary page 4…Trade Name: ClariVein® IC Classification Name: Continuous Flush Catheter Predicate Premarket Notification: K153502 Device Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject to a… | 2016 |
What descends from it? (2)
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 30 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K250794 (Invera Medical, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 ClariVein IC is indicated for the infusion of physician-specified agents in the peripheral vasculature (e.g., superficial veins, saphenous veins).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201907: ClariVein IC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201907
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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