510(k) · Cleared
Recalled · Class II · 2016Protectiv Acuvance IV Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 1, 2001 after a 23-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 1, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK012128 Protectiv Acuvance IV Catheter SystemEthicon Endo-Surgery, Inc. · 2001
- Descendant · cites it directly · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK162894 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK243105 Ruby Intravascular CatheterVenocare, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK260432 Ruby Intravascular CatheterVenocare, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · cites it directly7descendants
- K153298AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015 · 2 generations on5descendants
- K162894AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016 · 3 generations on4descendants
- K243105Ruby Intravascular CatheterVenocare, Inc. · 2025 · 4 generations on1descendant
- K260432Ruby Intravascular CatheterVenocare, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012128 | Protectiv Acuvance IV Catheter System | Ethicon Endo-Surgery, Inc. | 2001 | — |
| +1 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| +2 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
| +3 | K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2016 | — |
| +4 | K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025 | — |
| +5 | K260432 | Ruby Intravascular Catheter | Venocare, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
Planning a device in FOZ? 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 |
|---|---|---|---|
| * | — | PROTECTIV* ACUVANCE IV Catheter System Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140504 | Accucath BC Intravascular Catheter System | 2014 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2016 | Class II | Z-0789-2017 | Process control | Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140504 (Vascular Pathways, Inc., 2014) has gone furthest, with 7 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?
A properly placed LV. catheter provides access to a vein or artery. The LV. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
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/K012128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012128: Protectiv Acuvance IV Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012128
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026