# K192676: Introcan Safety 2 IV Catheter 18-24 gauge

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 1, 2020 after 188 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: 6 generations back to K801941 (1980). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182870: Introcan Safety 3 Closed IV Catheter, B.Braun Medical, Inc. (2019) Summary page 4.

## Most influential descendants
- 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
- K252513: Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (2026), 0 descendants of its own

## Indications for use
The 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 300 psi with a luer lock connection only.

Source page: https://510kreport.com/device/K192676
Methodology: https://510kreport.com/methodology