510(k) · Cleared
ClearedRuby Intravascular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venocare, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Sep 2, 2026 as substantially equivalent to K243105 (Venocare, Inc., 2025) after a 203-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Sep 2, 2026
- Review
- 203 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K854773 (1986). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 5 generations between
- 3 generations backK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
- 2 generations backK162894 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016
- 1 generation backK243105 Ruby Intravascular CatheterVenocare, Inc. · 2025
- This deviceK260432 Ruby Intravascular CatheterVenocare, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 8 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 7 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 6 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 5 generations backK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- 4 generations backK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- 3 generations backK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
- 2 generations backK162894 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016
- 1 generation backK243105 Ruby Intravascular CatheterVenocare, Inc. · 2025
- This deviceK260432 Ruby Intravascular CatheterVenocare, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −8 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −7 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −6 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| −5 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| −4 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| −3 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
| −2 | K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2016 | — |
| −1 | K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025 | — |
| 0 (this device) | K260432 | Ruby Intravascular Catheter | Venocare, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 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.
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 |
|---|---|---|---|
| * | K243105 | Ruby Intravascular CatheterSummary page 6…ation 21 CFR § 880.5200 Number Product Code FOZ 510(k) Number K243105 The RUBY Intravascular Catheter consists of a radiopaque catheter having a usable length of 1… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
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. 2026, 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 RUBY Intravascular Catheter is inserted into a patient’s vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The RUBY Intravascular Catheter is suitable for use with power injectors.
The 20 Gauge RUBY Intravascular Catheter is indicated for use in pediatric patients (with body mass higher or equal to 10 kg) and adults.
The 22 Gauge and 24 Gauge RUBY Intravascular Catheter are indicated for use in pediatric patients (with body mass higher or equal to 3.5 kg) and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260432: Ruby Intravascular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260432
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026