# K021094: Introcan Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 3, 2002 after 90 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801941 (1980). 5 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982805: Introcan Safety IV Catheter, B.Braun Medical, Inc. (1999) Summary page 1.
- K810460: Burron Percutaneous Inducer Set, Burron Medical Products, Inc. (1981) Summary page 1.
- K810461: Burron Central Vein Catherization Kit, Burron Medical Products, Inc. (1981) Summary page 1.
- K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer, Becton Dickinson Infusion Therapy Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K111236: Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 (2011), 15 descendants of its own
- K163358: Introcan Safety 3 Closed IV Catheter (2017), 9 descendants of its own
- K182870: Introcan Safety 3 Closed IV Catheter (2019), 8 descendants of its own
- K030135: Safety Introducer Needle (2003), 7 descendants of its own
- K192676: Introcan Safety 2 IV Catheter 18-24 gauge (2020), 6 descendants of its own

## Recalls of this device
- Sep 27, 2013 · Class II · Z-0559-2014: One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

## Indications for use
The Introcan® Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access 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/K021094
Methodology: https://510kreport.com/methodology