# K220626: Introcan Safety IV Catheter

- Pathway: 510(k) (Special)
- Applicant: B.Braun Medical, Inc.
- Decided: May 14, 2022 after 71 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: 3 generations back to K801941 (1980). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020785: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K253235: Introcan Safety® Deep Access XL IV Catheter (2026), 0 descendants of its own

## Indications for use
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. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

Source page: https://510kreport.com/device/K220626
Methodology: https://510kreport.com/methodology