# K213085: Introcan Safety 3 Closed IV Catheter

- Pathway: 510(k) (Special)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 25, 2021 after 31 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: 6 generations back to K801941 (1980). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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.

## 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 catheters may be used with power injectors at a maximum pressure of 325 psi with luer lock connection only.

Source page: https://510kreport.com/device/K213085
Methodology: https://510kreport.com/methodology