# K213664: B. Braun Introcan Safety 2 IV Catheter

- Pathway: 510(k) (Special)
- Applicant: B.Braun Medical, Inc.
- Decided: Feb 11, 2022 after 81 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: 7 generations back to K801941 (1980). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192676: Introcan Safety 2 IV Catheter 18-24 gauge, B.Braun Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K220756: Introcan Safety 2 IV Catheter (2022), 1 descendant of its own
- K260539: MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (2026), 0 descendants of its own
- K241845: Introcan Safety® 2 IV Catheter (2024), 0 descendants of its own

## Indications for use
The Introcan Safety® 2 IV Catheter is inserted into the patient’s vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe used intravascularly with power injectors at a maximum pressure of 300 psi with a luer lock connection only.

Source page: https://510kreport.com/device/K213664
Methodology: https://510kreport.com/methodology