# K252441: Primero Safe Access System

- Pathway: 510(k) (Traditional)
- Applicant: South53, LLC
- Decided: Sep 29, 2025 after 56 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K954234 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111606: Pinnacle Precision Access System, Terumo Medical Corp. (2011) Summary page 5.

## Indications for use
The Primero Safe Access System is intended to facilitate placing a catheter through the skin into a vein or artery. The introducer needle is used in facilitating entry through the skin into a vein or artery to provide a conduit for the guidewire. The guidewire is an accessory device which is used for placement of a catheter or sheath in the vein or artery.

Source page: https://510kreport.com/device/K252441
Methodology: https://510kreport.com/methodology