510(k) · Cleared
ClearedInsyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Infusion Therapy Systems, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 21, 2001 after a 36-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- Dec 21, 2001
- Review
- 36 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 7 citing it directly.
- This deviceK013800 Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard…Becton Dickinson Infusion Therapy Systems, Inc. · 2001
- Descendant · cites it directly · 28 of its ownK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- Descendant · cites it directly · 27 of its ownK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- Descendant · cites it directly · 21 of its ownK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- Descendant · 2 generations on · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- Descendant · 3 generations on · 5 of its ownK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K081953Supercath 5Togo Medikit Co., Ltd. · 2009 · cites it directly28descendants
- K093546Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009 · cites it directly27descendants
- K110443BD Insyte Autoguard BCBecton, Dickinson & CO · 2011 · cites it directly21descendants
- K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · 2 generations on7descendants
- K153298AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013800 | Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro… | Becton Dickinson Infusion Therapy Systems, Inc. | 2001 | — |
| +1 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| +1 | 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 | — |
| +2 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| +3 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | — | Insyte™ IV Catheter Named without a submission number | |
| * | — | Angiocath™ IV Catheter Named without a submission number | |
| * | — | Insyte™ Autoguard™ IV Catheter Named without a submission number | |
| * | — | Angiocath™ Autoguard™ IV Catheter Named without a submission number | |
| * | — | Autoguard™ Pro IV Catheter Named without a submission number | |
| * | — | Intima™ IV Catheter Named without a submission number | |
| * | — | Saf-T-Intima™ IV Catheter Named without a submission number |
What descends from it? (35)
See all 357 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081953 | Supercath 5 | 2009 | 28 |
| K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | 2009 | 27 |
| K110443 | BD Insyte Autoguard BC | 2011 | 21 |
| K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | 2015 | 2 |
| K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System | 2025 | 0 |
| K210929 | MagiCath II | 2022 | 0 |
| K192230 | MF Safecath | 2020 | 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?
- Of its descendants, K081953 (Togo Medikit Co., Ltd., 2009) has gone furthest, with 28 descendants 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.
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?
As provided in 21 CFR 880.5200, an intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
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/K013800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013800: Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013800
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026