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 May 16, 2025 as substantially equivalent to K162894 (C.R. Bard, Inc., 2016) after a 228-day review. Its family tree reaches back 8 generations to 1986. 1 later device descends from it.
- Decided
- May 16, 2025
- Review
- 228 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K854773 (1986). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 7 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 6 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 5 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 4 generations backK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- 3 generations backK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- 2 generations backK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
- 1 generation backK162894 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016
- This deviceK243105 Ruby Intravascular CatheterVenocare, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK260432 Ruby Intravascular CatheterVenocare, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260432Ruby Intravascular CatheterVenocare, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −7 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −6 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −5 | 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 | — |
| −3 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| −2 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
| −1 | K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2016 | — |
| 0 (this device) | K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K162894 | AccuCath Intravascular CatheterSummary page 5…21 CFR § 880.5200 Number Product Code FOZ 510(k) Number K162894 The RUBY™ Intravascular Catheter consists of a radiopaque catheter having a usable leng… | 2016 |
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 |
|---|---|---|---|
| K260432 | Ruby Intravascular Catheter | 2026 | 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 39 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K260432 (Venocare, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K162894.
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. 2025, 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 RUBY Intravascular Catheter is indicated for use in pediatric patients (with body mass higher or equal to 10 kg) and adults.
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/K243105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243105: Ruby Intravascular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243105
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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