510(k) · Cleared
ClearedAccucath BC Intravascular Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Pathways, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jul 17, 2014 as substantially equivalent to K110443 (Becton, Dickinson & CO, 2011) and 2 other predicates after a 140-day review. Its family tree reaches back 5 generations to 1986. 7 later devices descend from it.
- Decided
- Jul 17, 2014
- Review
- 140 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K854773 (1986). 12 ancestors in all. 7 later devices descend from it, 2 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 deviceK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK162894 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK243105 Ruby Intravascular CatheterVenocare, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK260432 Ruby Intravascular CatheterVenocare, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK233106 AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.) · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153298AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015 · cites it directly5descendants
- K162894AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016 · 2 generations on4descendants
- K243105Ruby Intravascular CatheterVenocare, Inc. · 2025 · 3 generations on1descendant
- K260432Ruby Intravascular CatheterVenocare, Inc. · 2026 · 4 generations on0descendants
- K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.) · 2024 · 3 generations on0descendants
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) | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| +1 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
| +2 | K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2016 | — |
| +3 | K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025 | — |
| +4 | K260432 | Ruby Intravascular Catheter | Venocare, Inc. | 2026 | — |
| +3 | K233106 | AccuCath Ace™ Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2024 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K110443 | BD Insyte Autoguard BCSummary page 2…vices: The AccuCath BC Intravascular Catheter System has the same intended use, mechanism of action, and basic design attributes as the BD INSYTE AUTOGUARD BC device (KI 110443), the Ethicon PROTECTIV* ACUVANCE IV Catheter System (K012 128) and the Vascular Pathways, Inc., Rapid Intravascular Catheter Sta… | 2011 |
| * | K012128 | Protectiv Acuvance IV Catheter SystemSummary page 2…same intended use, mechanism of action, and basic design attributes as the BD INSYTE AUTOGUARD BC device (KI 110443), the Ethicon PROTECTIV* ACUVANCE IV Catheter System (K012 128) and the Vascular Pathways, Inc., Rapid Intravascular Catheter Start System (KI 112347) (the predicate devices). It has the same… | 2001 |
| * | K112347 | Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeSummary page 1…TOGUARD BC device (KI 10443), Ethicon Endo-Surgery PROTECTIV* ACUVANCE IV Catheter System (1(012 128) Vascular Pathways, Inc., Rapid Intravascular Catheter Start System (K 112347) Device Description: The AccuCath BC Intravascular Catheter System has a usable length catheter of 2.25 inche s in 18, 20 and 22… | 2011 |
What descends from it? (7)
2 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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K153298 (C.R. Bard, Inc., 2015) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K110443.
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. 2014, 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 AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath BC is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140504: Accucath BC Intravascular 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/K140504
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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