# K013800: Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Dec 21, 2001 after 36 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
No predicates in its family tree.
35 later devices descend from it; 7 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Insyte™ IV Catheter: named in the summary without a submission number
- (no number) Angiocath™ IV Catheter: named in the summary without a submission number
- (no number) Insyte™ Autoguard™ IV Catheter: named in the summary without a submission number
- (no number) Angiocath™ Autoguard™ IV Catheter: named in the summary without a submission number
- (no number) Autoguard™ Pro IV Catheter: named in the summary without a submission number
- (no number) Intima™ IV Catheter: named in the summary without a submission number
- (no number) Saf-T-Intima™ IV Catheter: named in the summary without a submission number

## Most influential descendants
- K081953: Supercath 5 (2009), 28 descendants of its own
- K093546: Supercath 5 Model SP120-XX-XX, SP125-XX-XX (2009), 27 descendants of its own
- K110443: BD Insyte Autoguard BC (2011), 21 descendants of its own
- K140504: Accucath BC Intravascular Catheter System (2014), 7 descendants of its own
- K153298: AccuCath Intravascular Catheter (2015), 5 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K013800
Methodology: https://510kreport.com/methodology