# K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Jan 2, 2002 after 90 days
- Product code: DBY (Fab, Rhodamine, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
130 later devices descend from it; 4 cite it directly.
0 of 131 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) BD Introsyte™ Precision Introducer: named in the summary without a submission number
- (no number) BD Introsyte™ Autoguard™ Shielded Introducer: named in the summary without a submission number

## Most influential descendants
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set (2002), 100 descendants of its own
- K070440: BD Hypoint Needle (2007), 91 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own

## Indications for use
To facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

Source page: https://510kreport.com/device/K013304
Methodology: https://510kreport.com/methodology