510(k) · Cleared
ClearedAcuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV Catheter
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 Mar 28, 2003 after a 32-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Mar 28, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK030571 Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter…Ethicon Endo-Surgery, Inc. · 2003
- Descendant · cites it directly · 30 of its ownK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- Descendant · 2 generations on · 28 of its ownK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- Descendant · 3 generations on · 27 of its ownK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- Descendant · 4 generations on · 21 of its ownK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- Descendant · 5 generations on · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K050114Supercath Z3VTogo Medikit Co., Ltd. · 2005 · cites it directly30descendants
- K081953Supercath 5Togo Medikit Co., Ltd. · 2009 · 2 generations on28descendants
- K093546Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009 · 3 generations on27descendants
- K110443BD Insyte Autoguard BCBecton, Dickinson & CO · 2011 · 4 generations on21descendants
- K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030571 | Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV… | Ethicon Endo-Surgery, Inc. | 2003 | — |
| +1 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| +2 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| +3 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| +4 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| +5 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 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.
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? (3)
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 |
|---|---|---|---|
| * | — | ACUVANCE PLUS Safety IV Catheter Named without a submission number | |
| * | — | PROTECTIV PLUS Safety IV Catheter Named without a submission number | |
| * | — | OPTIVA IV Catheter Named without a submission number |
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050114 (Togo Medikit Co., Ltd., 2005) has gone furthest, with 30 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?
ACUVANCE PLUS Safety Tv Catheter: A properly placed 1.V. catheter provides access to a vein or art~ry. The I.V. 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…
Read the full statement (252 words)
ACUVANCE PLUS Safety Tv Catheter:
A properly placed 1.V. catheter provides access to a vein or art~ry. The I.V. 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 injector up to 300 psi.
PROTECTN PLUS Safety IV Catheter
The PROTECTN PLUS Safety I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or mery. The PROTECTIV PLUS Safety I-V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. These catheters may be used for any patient population with consideration given to patient size, appropriaceness for the solution being infused, and duration of therapy. 16G to 24G catheters may be used w i h power injectors up to 300 psi.
OFTIVA IV Catheter:
The OPTIVA I.V. Catheter is designed for single w e. A properly placed I.V. catheter provides access to a vein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of rhcrapy. 16G to 24G catheters may be used with power injectors up co 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030571: Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030571
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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