510(k) · Cleared
ClearedTriple Lumen Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jul 1, 2002 as substantially equivalent to K970864 (Arrow Intl., Inc., 1997) after a 280-day review. Its family tree reaches back 2 generations to 1982. 3 of the 6 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 1, 2002
- Review
- 280 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K820648 (1982). 5 ancestors in all. No later device cites it as a predicate yet. 3 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK820648 Arrow M.I.S. Multi-Lumen CatheterizaArrow Intl., Inc. · 1982 · Recalled
- 1 generation backK970864 Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Recalled (Class I)
- This deviceK013182 Triple Lumen Central Venous CatheterCook, Inc. · 2002
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820648 | Arrow M.I.S. Multi-Lumen Catheteriza | Arrow Intl., Inc. | 1982 | 7 |
| −1 | K970864 | Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters | Arrow Intl., Inc. | 1997 | Class I |
| 0 (this device) | K013182 | Triple Lumen Central Venous Catheter | Cook, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 1 |
| 1990 | 1 | 1 |
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.
3 devices in this family have a Class I recall. 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 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 |
|---|---|---|---|
| * | K970864 | Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersSummary page 1…ment) Arrow-Howes Large Bore Marketed & Distributed by Multi-lumen Central Arrow lnternational Venous Catheter K970864 Device Description The Triple Lumen Central Venous consists of a three-lumen, silicone shaft and manifold hub. With three separ… | 1997 |
| * | — | Cook Double Lumen Catheters Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 2 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
- 4 of the 5 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K970864.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
A vascular access catheter used for, infusion and withdrawat of brood, blood products, and ff uids, central venous blood pressure monitoring (CVP), acute hyperalimentation, continuous or intermittent drug infusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013182: Triple Lumen Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013182
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026