510(k) · Cleared
ClearedMulti-Sideport Catheter Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KRA Catheter, Continuous Flush
Cleared on Apr 25, 2019 as substantially equivalent to K991619 (Merit Medical Systems, Inc., 1999) after a 267-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Apr 25, 2019
- Review
- 267 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904788 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 2 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 1 generation backK991619 FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1999
- This deviceK182071 Multi-Sideport Catheter Infusion SetCook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −2 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −1 | K991619 | FOUNTAIN Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K182071 | Multi-Sideport Catheter Infusion Set | Cook Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K991619 | FOUNTAIN Infusion Catheter and Occluding Guide WireSummary page 4…KRA (21 CFR §870.1210) Predicate Device The predicate device is the Merit Medical Systems Inc. Fountain Infusion System cleared under 510(k) number K991619. The predicate device is manufactured in a diameter of 5.0 French and in lengths of 45 - 135 centimeters. The catheter is compati… | 1999 |
| † | K170258 | SpeedLyser Infusion Catheter Kit | 2017 |
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 29 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K991619.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182071: Multi-Sideport Catheter Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182071
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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