510(k) · Cleared
ClearedBD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
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 Jun 27, 2025 as substantially equivalent to K201075 (Becton, Dickinson and Company, 2020) after a 28-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Jun 27, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K854773 (1986). 16 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet.
- Root · 6 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 5 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 4 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 3 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 2 generations backK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- 1 generation backK201075 BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC…Becton, Dickinson and Company · 2020 · Recalled
- This deviceK251654 BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC…Becton Dickinson Infusion Therapy Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −5 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −4 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −3 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| −2 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| −1 | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV… | Becton, Dickinson and Company | 2020 | 11 |
| 0 (this device) | K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded… | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Summary page 5…uard™ BC Shielded IV Catheter BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter 510(k) Reference: K201075 Common Name: Peripheral Intravascular or IV Catheter/Catheter Introducer Regul… | 2020 |
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 39 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 16 ancestors have 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. 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?
BD Insyte™ Autoguard™ Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device may be used for any patient population with consideration given to adequacy of vascular anatomy…
Read the full statement (265 words)
BD Insyte™ Autoguard™ Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
BD Insyte™ Autoguard™ BC Shielded IV Catheter is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251654: BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251654
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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