510(k) · Cleared
ClearedArgon Multi-Lumen Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxim Medical · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 5, 1999 as substantially equivalent to K960764 (Scientific Device Manufacturer, LLC, 1997) after a 163-day review. Its family tree reaches back 1 generation to 1997. 1 of the 36 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it.
- Decided
- May 5, 1999
- Review
- 163 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960764 (1997). 34 later devices descend from it, 1 citing it directly. 1 of the 36 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK960764 Safe-CathScientific Device Manufacturer, LLC · 1997
- This deviceK984189 Argon Multi-Lumen Central Venous CatheterMaxxim Medical · 1999
- Descendant · cites it directly · 33 of its ownK032274 Cook Five Lumen Central Venous CatheterCook, Inc. · 2004
- Descendant · 2 generations on · 32 of its ownK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
- Descendant · 2 generations on · 31 of its ownK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 4 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131260 Nmi Dialysis Catheter5 generations on · 2014
Most influential descendants
Showing 5 of 34 · See all- K032274Cook Five Lumen Central Venous CatheterCook, Inc. · 2004 · cites it directly33descendants
- K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006 · 2 generations on32descendants
- K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · 2 generations on31descendants
- K101326NMI ICNavilyst Medical, Inc. · 2010 · 3 generations on26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960764 | Safe-Cath | Scientific Device Manufacturer, LLC | 1997 | — |
| 0 (this device) | K984189 | Argon Multi-Lumen Central Venous Catheter | Maxxim Medical | 1999 | — |
| +1 | K032274 | Cook Five Lumen Central Venous Catheter | Cook, Inc. | 2004 | — |
| +2 | K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm | Cook, Inc. | 2006 | — |
| +2 | K081113 | Cook and Cook Spectrum Central Venous Catheters | Cook, Inc. | 2008 | 105 |
| +3 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +4 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 1 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K960764 | Safe-CathSummary page 1…Fax: 903-677-9397 Contact person: Eddie Monroe, VP QA/RA Date prepared: Movesmber / g , /775 Legally marketed device to which equivalence is claimed: Medex Safe-Cath K960764 Description of Device: (4777 fi The Argon multi-lumen central venous catheter has a polyurethane body with multiple - lumens. TQ’… | 1997 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032274 | Cook Five Lumen Central Venous Catheter | 2004 | 33 |
Has anything in its family been recalled? (1 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.
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K032274 (Cook, Inc., 2004) has gone furthest, with 33 descendants of its own.
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?
Multi-lumen central venous catheters are used to measure central venous pressure, to
infuse fluids, to sample venous blood and to infuse parenteral nutrition (TPN) or
medications.
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/K984189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984189: Argon Multi-Lumen Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984189
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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