510(k) · Cleared
ClearedViavalve Safety IV Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 14, 2012 as substantially equivalent to K990236 (Johnson & Johnson Medical, Div. of Ethicon, Inc., 1999) and 1 other predicate after an 89-day review. Its family tree reaches back 5 generations to 1986. 1 later device descends from it.
- Decided
- Mar 14, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K854773 (1986). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 4 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 3 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 2 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 1 generation backK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- This deviceK113700 Viavalve Safety IV CatheterSmiths Medical Asd, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK160235 ViaValve Safety I.V. CatheterSmiths Medical Asd, Inc. · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K160235ViaValve Safety I.V. CatheterSmiths Medical Asd, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −4 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −3 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −2 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| −1 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| 0 (this device) | K113700 | Viavalve Safety IV Catheter | Smiths Medical Asd, Inc. | 2012 | — |
| +1 | K160235 | ViaValve Safety I.V. Catheter | Smiths Medical Asd, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K990236 | Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters…Summary page 1…Catheter Common Name: Peripheral I.V. Catheter Classification Name: 880.5200 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Predicate Device(s): K990236 (ProtectlV® and ProtectlV0 Plus Safety LV . Catheter) - Marketed by Smiths Medical ASD, Inc. El110443 (BD InSyte T"Autoguard" BC… | 1999 |
| * | K110443 | BD Insyte Autoguard BCSummary page 1…Therapeutic, Short-Term Less Than 30 Days Predicate Device(s): K990236 (ProtectlV® and ProtectlV0 Plus Safety LV . Catheter) - Marketed by Smiths Medical ASD, Inc. El110443 (BD InSyte T"Autoguard" BC Shielded L;V. Catheter) - Marketed by Becton Dickinson (BD) & Co. Device Description: The ViaValve TM… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160235 | ViaValve Safety I.V. Catheter | 2016 | 0 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K160235 (Smiths Medical Asd, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K990236.
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?
A properly placed ViaValve™ Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. 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. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113700: Viavalve Safety 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/K113700
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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