# K252677: Polyshield Safety IV Catheters

- Pathway: 510(k) (Special)
- Applicant: Poly Medicure Limited
- Decided: Nov 5, 2025 after 72 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 K854773 (1986). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230616: Polyguard and Polyshield Safety IV Catheters, Poly Medicure Limited (2023) Summary page 6.

## Indications for use
The Polyshield Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient’s vascular system to sample blood, monitor blood pressure, or administer fluids. 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 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

Source page: https://510kreport.com/device/K252677
Methodology: https://510kreport.com/methodology