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Autonomous Medical Devices Incorporated: FDA-registered device maker in Santa Ana, CA, United States, 1 510(k) clearance

Name: Autonomous Medical Devices Incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Autonomous Medical Devices Incorporated is registered with the FDA (registration 3023999024) in Santa Ana, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 12, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3023999024
Address: 3511 W Sunflower Ave, Santa Ana, CA, United States, 92704
Owner or operator: Autonomous Medical Devices Incorporated (10096063)
Roles: Complaint file establishment, Manufacturer
First device listed: June 16, 2026
Registered through: 2026
Brand names listed: Fast PCR Instrument, Fast PCR Mini Respiratory Panel, Fast PCR Mini Respiratory Panel Negative External Control, Fast PCR Mini Respiratory Panel Positive External Control

Devices it lists

Device	Product code	Class	Role	Source
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	PMN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Complaint file establishment, 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
June 12, 2026	K252932	Fast PCR Mini Respiratory Panel	QOF	Substantially Equivalent	Autonomous Medical Devices Incorporated	accessdata.fda.gov

Compare with other makers

Updated June 12, 2026. 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.