# K201075: BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 18, 2020 after 240 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K854773 (1986). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952861: Angiocath & Insyte Autoguard Catheters, Becton Dickinson Vascular Access, Inc. (1995) Summary page 4.
- K110443: BD Insyte Autoguard BC, Becton, Dickinson & CO (2011) Summary page 5.
- K021094: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 5.

## Most influential descendants
- K251654: BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (2025), 0 descendants of its own

## Recalls of this device
- May 21, 2025 · Class II · Z-2003-2025: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 

## Indications for use
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).

Source page: https://510kreport.com/device/K201075
Methodology: https://510kreport.com/methodology