Data / Medical devices / United States / South53

South53: FDA-registered device maker in San Juan Capistrano, CA, United States, 1 510(k) clearance

South53 is registered with the FDA (registration 3037047821) in San Juan Capistrano, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3037047821

Address

27131 Calle Arroyo Ste 1722, San Juan Capistrano, CA, United States, 92675

Owner or operator

South53 (10094165)

Roles

Manufacturer

First device listed

November 19, 2025

Registered through

2026

Brand names listed

Primero Safe Access System

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

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Updated September 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.