Data / Medical devices / United States / Neptune Medical, Inc

Neptune Medical, Inc: FDA-registered device maker in Burlingame, CA, United States, 6 510(k) clearances

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

Neptune Medical, Inc is registered with the FDA (registration 3015451828) in Burlingame, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 3, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015451828
Address: 1828 El Camino Real 5th Floor, Burlingame, CA, United States, 94010
Owner or operator: Neptune Medical, Inc (10061389)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: October 14, 2019
Registered through: 2026
Brand names listed: Pathfinder, Pathfinder CR System, Pathfinder Endoscope Cap, Pathfinder Endoscope Overtube, Pathfinder SB, Tape Cut Guide, Triton 1 System

Devices it lists

Device	Product code	Class	Role	Source
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	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
September 3, 2026	K260503	Triton 1 System	FDF	Substantially Equivalent	Neptune Medical, Inc.	accessdata.fda.gov
June 27, 2024	K240853	Pathfinder® CR System	FED	Unknown	Neptune Medical, Inc.	accessdata.fda.gov
July 28, 2023	K230801	Pathfinder Endoscope Overtube with Balloon Device	FED	Substantially Equivalent	Neptune Medical, Inc.	accessdata.fda.gov
May 28, 2021	K211301	Pathfinder Endoscope Overtube	FED	Substantially Equivalent	Neptune Medical, Inc.	accessdata.fda.gov
May 25, 2021	K210915	Pathfinder Endoscope Cap	FDS	Substantially Equivalent	Neptune Medical, Inc.	accessdata.fda.gov
August 30, 2019	K191415	Pathfinder Endoscope Overtube	FED	Substantially Equivalent	Neptune Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 3, 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.