# 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

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Melsungen AG
- Decided: Aug 30, 2011 after 120 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K801941 (1980). 10 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021094: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 1.
- K020785: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 1.
- K032843: Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K192676: Introcan Safety 2 IV Catheter 18-24 gauge (2020), 6 descendants of its own
- K172506: BD Cathena Safety IV Catheter (2017), 4 descendants of its own
- K213664: B. Braun Introcan Safety 2 IV Catheter (2022), 3 descendants of its own

## Recalls of this device
- Feb 17, 2025 · Class II · Z-1397-2025: Increased risk for valve housing detachment causing leakage.

## Indications for use
Introcan Safetrs 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure or administer fluids and blood intravascularly. The 18-22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi with a luer lock connection only.

Source page: https://510kreport.com/device/K111236
Methodology: https://510kreport.com/methodology