510(k) · Cleared
ClearedAccuCath Intravascular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Nov 15, 2016 as substantially equivalent to K153298 (C.R. Bard, Inc., 2015) after a 29-day review. Its family tree reaches back 7 generations to 1986. 4 later devices descend from it.
- Decided
- Nov 15, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K854773 (1986). 14 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 6 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 5 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 4 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 3 generations backK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- 2 generations backK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- 1 generation backK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
- This deviceK162894 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK243105 Ruby Intravascular CatheterVenocare, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260432 Ruby Intravascular CatheterVenocare, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK233106 AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.) · 2024
- Descendant · cites it directly · 0 of its ownK191232 AccuCath Ace Intravascular CatheterC.R. Bard, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K243105Ruby Intravascular CatheterVenocare, Inc. · 2025 · cites it directly1descendant
- K260432Ruby Intravascular CatheterVenocare, Inc. · 2026 · 2 generations on0descendants
- K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.) · 2024 · cites it directly0descendants
- K191232AccuCath Ace Intravascular CatheterC.R. Bard, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −6 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −5 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −4 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| −3 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| −2 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| −1 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
| 0 (this device) | K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2016 | — |
| +1 | K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025 | — |
| +2 | K260432 | Ruby Intravascular Catheter | Venocare, Inc. | 2026 | — |
| +1 | K233106 | AccuCath Ace™ Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2024 | — |
| +1 | K191232 | AccuCath Ace Intravascular Catheter | C.R. Bard, Inc. | 2019 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K153298 | AccuCath Intravascular CatheterSummary page 4…Classification Panel: General Hospital Predicate Trade Name: AccuCath™ Intravascular Catheter Premarket Notification: K153298 (cleared December 10, 2015) Manufacturer: Bard Access Systems, Inc. Predicate Common Name:… | 2015 |
What descends from it? (4)
3 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 30 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K243105 (Venocare, Inc., 2025) has gone furthest, with 1 descendant 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. 2016, 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 Intravascular Catheter 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 IV Catheter is suitable for use with power injectors.
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/K162894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162894: AccuCath 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/K162894
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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