# K110443: BD Insyte Autoguard BC

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 19, 2011 after 153 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854773 (1986). 7 ancestors in all.
21 later devices descend from it; 7 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013800: Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete, Becton Dickinson Infusion Therapy Systems, Inc. (2001) Summary page 1.
- K093546: Supercath 5 Model SP120-XX-XX, SP125-XX-XX, Togo Medikit Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K140504: Accucath BC Intravascular Catheter System (2014), 7 descendants of its own
- K153298: AccuCath Intravascular Catheter (2015), 5 descendants of its own
- K172506: BD Cathena Safety IV Catheter (2017), 4 descendants of its own
- K162894: AccuCath Intravascular Catheter (2016), 4 descendants of its own
- K192493: BD Cathena (TM) Safety IV Catheter (2020), 3 descendants of its own

## Indications for use
The BD Insyte Autoguard BC catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids.

Source page: https://510kreport.com/device/K110443
Methodology: https://510kreport.com/methodology