# K182870: Introcan Safety 3 Closed IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 7, 2019 after 146 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: 5 generations back to K801941 (1980). 12 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, B.Braun Melsungen AG (2011) Summary page 4.
- K163358: Introcan Safety 3 Closed IV Catheter, B.Braun Melsungen AG (2017) Summary page 4.

## Most influential descendants
- K192676: Introcan Safety 2 IV Catheter 18-24 gauge (2020), 6 descendants of its own
- K213664: B. Braun Introcan Safety 2 IV Catheter (2022), 3 descendants of its own
- K231401: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (2023), 1 descendant of its own
- 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

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

## Indications for use
Introcan Safety® 3 Closed Intravascular 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 18-24-gauge catheters may be used with power injectors at a maximum pressure of 300 psi with luer lock connection only.

Source page: https://510kreport.com/device/K182870
Methodology: https://510kreport.com/methodology