510(k) · Cleared
Recalled · Class II · 2025BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, 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 and Company · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 18, 2020 as substantially equivalent to K952861 (Becton Dickinson Vascular Access, Inc., 1995) and 2 other predicates after a 240-day review. Its family tree reaches back 5 generations to 1986. 1 later device descends from it. It has been recalled 11 times.
- Decided
- Dec 18, 2020
- Review
- 240 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 5 generations to K854773 (1986). 15 ancestors in all, the oldest K801941 (1980). 1 later device descends from it, 1 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 deviceK201075 BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC…Becton, Dickinson and Company · 2020
- Descendant · cites it directly · 0 of its ownK251654 BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC…Becton Dickinson Infusion Therapy Systems, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc. · 2025 · cites it directly0descendants
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) | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV… | Becton, Dickinson and Company | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K952861 | Angiocath & Insyte Autoguard CathetersSummary page 4…Classification Panel: General Hospital Predicate Trade Name: BD Insyte™ Autoguard™ Shielded IV Catheter Device 510(k) Reference: K952861 Common Name: Peripheral Intravascular or IV Catheter Regulation Number: 21 CFR… | 1995 |
| * | K110443 | BD Insyte Autoguard BCSummary page 5…Page 1 of 14 Predicate Trade Name: BD Insyte™ Autoguard™ BC Shielded IV Catheter Device 510(k) Reference: K110443 Common Name: Peripheral Intravascular or IV Catheter Regulation Number: 21 CFR §880.5200… | 2011 |
| * | K021094 | Introcan Safety IV CatheterSummary page 5…e: FOZ Classification Panel: General Hospital Predicate Trade Name: Introcan® Safety™ IV Catheter Device 510(k) Reference: K021094 Common Name: Peripheral Intravascular or IV Catheter/ Catheter Introdu… | 2002 |
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 |
|---|---|---|---|
| K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2025 | Class II | Z-2003-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-2004-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-2007-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-2000-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-2006-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-2001-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-1999-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-2002-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Class II | Z-2005-2025 | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| Jun 26, 2024 | Class II | Z-2458-2024 | Process control | Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. |
| Oct 4, 2023 | Class II | Z-0400-2024 | Nonconforming Material/Component | Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K251654 (Becton Dickinson Infusion Therapy Systems, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K952861.
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. 2020, 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 Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may also be used to facilitate the placement of guidewires and other vascular access devices without pre-attached hubs.These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being…
Read the full statement (260 words)
BD Insyte™ Autoguard™ Shielded IV Catheters are intended to be inserted into a patient's peripheral vascular system for
short term use to sample blood, monitor blood pressure, or administer fluids. These devices may also be used to facilitate
the placement of guidewires and other vascular access devices without pre-attached hubs.These devices 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 (0.9-1.3mm) devices are suitable for use with power injectors set to a
maximum pressure of 300 psi (2068kPa).
BD Insyte™ Autoguard™ BC shielded IV catheters are intended to be inserted into a patient’s peripheral vascular system
for short term use to sample blood, monitor blood pressure, or administer fluids. These devices 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 Pro shielded IV catheters are intended to be inserted into a patient’s peripheral vascular
system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices 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/K201075 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201075: BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, 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 3, 2026. https://510kreport.com/device/K201075
Report an extraction error
Are you the manufacturer?
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