510(k) · Cleared
Recalled · Class I · 2016Multi-Med Multi-Lumen Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Edwards · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 25, 1996 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 25, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1 (1 Class I)
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK955839 Multi-Med Multi-Lumen Central Venous CatheterBaxter Edwards · 1996
- Descendant · cites it directly · 2 of its ownK091709 Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK160747 Angel CatheterBio2 Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK113565 Multi-Med Central Venous Catheters (CVCS), with and Without Heparin…Edwards Lifesciences, LLC · 2012
Most influential descendants
Showing 3 of 3 · See all- K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009 · cites it directly2descendants
- K160747Angel CatheterBio2 Medical, Inc. · 2016 · 2 generations on0descendants
- K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955839 | Multi-Med Multi-Lumen Central Venous Catheter | Baxter Edwards | 1996 | — |
| +1 | K091709 | Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC | Edwards Lifesciences, LLC | 2009 | — |
| +2 | K160747 | Angel Catheter | Bio2 Medical, Inc. | 2016 | — |
| +1 | K113565 | Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex… | Edwards Lifesciences, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2016 | Class I | Z-0647-2017 | Process control | The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It is possible that the excess material may separate from the catheter during… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091709 (Edwards Lifesciences, LLC, 2009) has gone furthest, with 2 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/K955839 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955839: Multi-Med 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/K955839
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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