Data / Medical devices / United States / BioticsAI, Inc.

BioticsAI, Inc.: FDA-registered device maker in San Francisco, CA, United States, 1 510(k) clearance

Name: BioticsAI, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

BioticsAI, Inc. is registered with the FDA (registration 3047889344) in San Francisco, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3047889344
Address: 455 Market St Ste 1940 Pmb 696426, San Francisco, CA, United States, 94105
Owner or operator: BioticsAI INC. (10096248)
Roles: Manufacturer
First device listed: August 5, 2026
Registered through: 2026
Brand names listed: BioticsAI

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov

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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 22, 2025	K250959	BioticsAI	IYN	Substantially Equivalent	Bioticsai, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 22, 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.