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The Tracker / September 2025 / K252441

510(k) cleared

Primero Safe Access System

South53, LLC · Sep 29, 2025 · K252441

FDA cleared the Primero Safe Access System from South53, LLC on Sep 29, 2025 under K252441, a traditional 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 4, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for South53, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252441?

K252441 is the FDA 510(k) for Primero Safe Access System, submitted by South53, LLC. FDA's decision date was Sep 29, 2025, under product code DYB (Introducer, Catheter).

Who makes the Primero Safe Access System?

South53, LLC, based in San Juan Capistrano, CA, is the applicant of record for K252441.

How long did the K252441 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Sep 29, 2025, 56 days later.

← All decisions in September 2025