510(k) · Cleared
ClearedMulti-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central Venous Catheters (CVCS), with Heparin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 18, 2012 as substantially equivalent to K955839 (Baxter Edwards, 1996) and 4 other predicates after a 168-day review. Its family tree reaches back 10 generations to 2000. 5 of the 33 devices in its family, counting itself, have a Class I recall.
- Decided
- May 18, 2012
- Review
- 168 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K001901 (2000). 32 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 5 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 2 generations backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- 1 generation backK091709 Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009
- This deviceK113565 Multi-Med Central Venous Catheters (CVCS), with and Without Heparin…Edwards Lifesciences, LLC · 2012
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 5 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 4 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 2 generations backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- 1 generation backK091709 Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009
- This deviceK113565 Multi-Med Central Venous Catheters (CVCS), with and Without Heparin…Edwards Lifesciences, LLC · 2012
Class I recalls in this family
- K955839 Multi-Med Multi-Lumen Central Venous Catheterdirect predicate · 1996
- K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…2 generations back · 2007
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…3 generations back · 2000
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter3 generations back · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −5 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −4 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −3 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −2 | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous… | Arrow International, Inc. | 2007 | Class I |
| −1 | K091709 | Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC | Edwards Lifesciences, LLC | 2009 | — |
| 0 (this device) | K113565 | Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex… | Edwards Lifesciences, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1989 | 1 | 0 |
| 1990 | 1 | 1 |
| 1994 | 1 | 0 |
| 1996 | 2 | 1 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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.
5 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? (5)
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 |
|---|---|---|---|
| * | K955839 | Multi-Med Multi-Lumen Central Venous CatheterSummary page 1…ntral Venous Catheters Classification Name: Intravascular Catheter (21 CFR Part 880.5200) Product Class/ Product Code: Class ll/FOZ Predicate Devices: K955839: Multi-Med Multi-Lumen CVCs K992532: Vantex CVCs with Oligon Material K09 1709: Multi-Med C… | 1996 |
| * | K992532 | Vantex Central Venous Catheter with Oligon Material with or Without Amc Thromboshield…Summary page 1…Intravascular Catheter (21 CFR Part 880.5200) Product Class/ Product Code: Class ll/FOZ Predicate Devices: K955839: Multi-Med Multi-Lumen CVCs K992532: Vantex CVCs with Oligon Material K09 1709: Multi-Med CVCs and Vantex CVCs K100739: VolumeV… | 2000 |
| * | K091709 | Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICSummary page 1…s/ Product Code: Class ll/FOZ Predicate Devices: K955839: Multi-Med Multi-Lumen CVCs K992532: Vantex CVCs with Oligon Material K09 1709: Multi-Med CVCs and Vantex CVCs K100739: VolumeView System KI 110167: PreSep Oligon Oximetr… | 2009 |
| * | K100739 | Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5Summary page 1…9: Multi-Med Multi-Lumen CVCs K992532: Vantex CVCs with Oligon Material K09 1709: Multi-Med CVCs and Vantex CVCs K100739: VolumeView System KI 110167: PreSep Oligon Oximetry Catheters Device The Multi-Med Central Venou… | 2010 |
| * | K110167 | Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Summary page 1…K992532: Vantex CVCs with Oligon Material K09 1709: Multi-Med CVCs and Vantex CVCs K100739: VolumeView System KI 110167: PreSep Oligon Oximetry Catheters Device The Multi-Med Central Venous Catheters (Multi-Med CVCs) and Description:… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K955839Multi-Med Multi-Lumen Central Venous CatheterBaxter Edwards · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 3 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 3 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 32 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K955839.
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. 2012, this device’s year, is highlighted.
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 Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
The Vantex central venous catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media. All catheters include a soft tip to reduce the risk of vessel perforation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113565: Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central Venous Catheters (CVCS), with Heparin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113565
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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