510(k) · Cleared
ClearedMedcomp Quad Lumen, 8.5F X 20CM, Model MC4L-8S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 23, 2001 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 35 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it.
- Decided
- Feb 23, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 2 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- This deviceK010021 Medcomp Quad Lumen, 8.5F X 20CM, Model MC4L-8SMedical Components, Inc. · 2001
- Descendant · cites it directly · 33 of its ownK032274 Cook Five Lumen Central Venous CatheterCook, Inc. · 2004
- Descendant · cites it directly · 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 · cites it directly32descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K010021 | Medcomp Quad Lumen, 8.5F X 20CM, Model MC4L-8S | Medical Components, Inc. | 2001 | — |
| +1 | K032274 | Cook Five Lumen Central Venous Catheter | Cook, Inc. | 2004 | — |
| +1 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (34)
See all 342 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 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 | — |
https://510kreport.com/device/K010021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010021: Medcomp Quad Lumen, 8.5F X 20CM, Model MC4L-8S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010021
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026