510(k) · Cleared
ClearedVaricath Peripheral Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veinrx, Inc. · KRA Catheter, Continuous Flush
Cleared on Dec 20, 2007 as substantially equivalent to K041517 (Id, LLC, 2004) and 1 other predicate after a 16-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Dec 20, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K904788 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- 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 backK041517 InfusioncathId, LLC · 2004
- 1 generation backK052738 Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016…Veinrx, Inc. · 2005
- This deviceK073400 Varicath Peripheral Infusion CatheterVeinrx, Inc. · 2007
View 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 | K041517 | Infusioncath | Id, LLC | 2004 | — |
| −1 | K052738 | Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024… | Veinrx, Inc. | 2005 | — |
| 0 (this device) | K073400 | Varicath Peripheral Infusion Catheter | Veinrx, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K041517 | InfusioncathSummary page 1…ician specified fluids, including thrombolytics, into the peripheral vasculature. Predicate Devices InfusionCath Peripheral Infusion Catheter K041517 & K052738 Manufactured by VeinRx, Inc. Device Description The VeinRx VariCath Peripheral Infusion Catheter is comprised… | 2004 |
| * | K052738 | Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028…Summary page 1…ified fluids, including thrombolytics, into the peripheral vasculature. Predicate Devices InfusionCath Peripheral Infusion Catheter K041517 & K052738 Manufactured by VeinRx, Inc. Device Description The VeinRx VariCath Peripheral Infusion Catheter is comprised of a dist… | 2005 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K041517.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 VariCath Peripheral Infusion Catheter is intended for infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073400 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073400: Varicath Peripheral Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073400
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