510(k) · Cleared
ClearedKavs - Catheter, Models 1107100 & 1107060
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richter & Rothe AG · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Mar 20, 2006 as substantially equivalent to K041517 (Id, LLC, 2004) and 1 other predicate after a 164-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Mar 20, 2006
- Review
- 164 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904788 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 4 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 3 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 2 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 1 generation backK041517 InfusioncathId, LLC · 2004
- This deviceK052844 Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −4 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −3 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −2 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −1 | K041517 | Infusioncath | Id, LLC | 2004 | — |
| 0 (this device) | K052844 | Kavs - Catheter, Models 1107100 & 1107060 | Richter & Rothe AG | 2006 | — |
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 |
| 2001 | 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 MJN? 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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…: Manufacturer Device 510(k) # VeinRx InfusionCath K041517 Cook Inc. LDOB Occlusion Balloon Catheter K002286 d. Description The KAVS catheter… | 2004 |
| * | K002286 | Ldob Occlusion Balloon CatheterSummary page 1…) # VeinRx InfusionCath K041517 Cook Inc. LDOB Occlusion Balloon Catheter K002286 d. Description The KAVS catheter is an intravascular catheter that is introduced into the patient's vein for shor… | 2001 |
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 16 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 MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052844: Kavs - Catheter, Models 1107100 & 1107060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052844
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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