# K220756: Introcan Safety 2 IV Catheter

- Pathway: 510(k) (Special)
- Applicant: B.Braun Medical, Inc.
- Decided: Jun 23, 2022 after 100 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: 8 generations back to K801941 (1980). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213664: B. Braun Introcan Safety 2 IV Catheter, B.Braun Medical, Inc. (2022) Summary page 4.

## Most influential descendants
- K241845: Introcan Safety® 2 IV Catheter (2024), 0 descendants of its own

## Indications for use
Introcan Safety® 2 IV Catheter is inserted into a patient’s vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly. The catheters may be used intravascularly with power Injectors at a maximum pressure of 325 psi with a luer lock connection only.

Source page: https://510kreport.com/device/K220756
Methodology: https://510kreport.com/methodology