# K020834: BD Introsyte Precision Introducer; BD Introsyte-N Precision Introducer; BD Introsyte Autoguard Shielded Introducer; BD I

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Jun 12, 2002 after 90 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
37 later devices descend from it; 5 cite it directly.
0 of 38 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-NT™ 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
- (no number) BD Introsyte-NT™ Autoguard™ Shielded Introducer: named in the summary without a submission number
- (no number) BD Splittable Needle Introducer: named in the summary without a submission number

## Most influential descendants
- K090372: The Wand Microaccess Safety Introducer (2009), 32 descendants of its own
- K093022: The Picc Wand Peelable Safety Introducer (2010), 31 descendants of its own
- K081697: The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006 (2008), 27 descendants of its own
- K101422: The Power Wand Safety Introducer with an Extended Dwell Catheter (2011), 25 descendants of its own
- K121073: Powerglide Midline Catheter (2012), 19 descendants of its own

## Indications for use
As provided in 21 CFR 870.1340, a catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Source page: https://510kreport.com/device/K020834
Methodology: https://510kreport.com/methodology