510(k) · Cleared
ClearedSpectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm
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 Feb 17, 2006 as substantially equivalent to K032274 (Cook, Inc., 2004) and 3 other predicates after a 25-day review. Its family tree reaches back 3 generations to 1997. 1 of the 41 devices in its family, counting itself, has a Class I recall. 32 later devices descend from it.
- Decided
- Feb 17, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K960764 (1997). 8 ancestors in all, the oldest K904404 (1991). 32 later devices descend from it, 1 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK960764 Safe-CathScientific Device Manufacturer, LLC · 1997
- 2 generations backK984189 Argon Multi-Lumen Central Venous CatheterMaxxim Medical · 1999
- 1 generation backK032274 Cook Five Lumen Central Venous CatheterCook, Inc. · 2004
- This deviceK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
- Descendant · cites it directly · 31 of its ownK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 3 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
- Descendant · 3 generations on · 14 of its ownK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- Descendant · 4 generations on · 12 of its ownK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131260 Nmi Dialysis Catheter4 generations on · 2014
Most influential descendants
Showing 5 of 32 · See all- K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · cites it directly31descendants
- K101326NMI ICNavilyst Medical, Inc. · 2010 · 2 generations on26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 3 generations on23descendants
- K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011 · 3 generations on14descendants
- K122882Nmi Hpicc IiiNavilyst Medical, Inc. · 2012 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960764 | Safe-Cath | Scientific Device Manufacturer, LLC | 1997 | — |
| −2 | K984189 | Argon Multi-Lumen Central Venous Catheter | Maxxim Medical | 1999 | — |
| −1 | K032274 | Cook Five Lumen Central Venous Catheter | Cook, Inc. | 2004 | — |
| 0 (this device) | K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm | Cook, Inc. | 2006 | — |
| +1 | K081113 | Cook and Cook Spectrum Central Venous Catheters | Cook, Inc. | 2008 | 105 |
| +2 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +3 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
| +3 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| +4 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K032274 | Cook Five Lumen Central Venous Catheter | 2004 |
| * | K033843 | Spectrum Central Venous Catheter with or Without Hydrophilic Coating | 2004 |
| * | K962577 | Arrowgard Blue Quad-Lumen Central Venous CatheterSummary page 2…orporated Spectrum and Spcct ruLn (ilide Central Venous Catheter Set (D.C. NKO33843), the Arrow International Arrowgai-cd Buc Quad-Luumen Central Venous Catheter (D.C. /#K962577), and the Medical Components Medcomp Quad Lumen (D.C.fKOI 0021). The similar indications tbr use, principles of operation. techn… | 1997 |
| * | K010021 | Medcomp Quad Lumen, 8.5F X 20CM, Model MC4L-8S | 2001 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081113 | Cook and Cook Spectrum Central Venous Catheters | 2008 | 31 |
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 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K081113 (Cook, Inc., 2008) has gone furthest, with 31 descendants of its own.
- 1 other device also cites its predicate K032274.
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?
The Spectrum Five Lumen Central Venous Catheter Set is indicated for the intravenous administration of nutrients, fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060174: Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060174
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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