# K230616: Polyguard and Polyshield Safety IV Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Poly Medicure Limited
- Decided: May 5, 2023 after 60 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: 5 generations back to K854773 (1986). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110443: BD Insyte Autoguard BC, Becton, Dickinson & CO (2011) Summary page 4.

## Most influential descendants
- K252677: Polyshield Safety IV Catheters (2025), 0 descendants of its own

## Indications for use
The Polyshield and Polyguard 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/K230616
Methodology: https://510kreport.com/methodology