# K231401: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

- Pathway: 510(k) (Traditional)
- Applicant: Poly Medicure Limited
- Decided: Sep 21, 2023 after 129 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.
1 later device descends from it; 1 cites it directly.
0 of 16 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.
- K020785: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- 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 Polysafety BC IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 18G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. The Polysafety BC Adva IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The l 8G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. The Polywin Safety IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. The Polywin Safety Adva IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

Source page: https://510kreport.com/device/K231401
Methodology: https://510kreport.com/methodology