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Abmrc LLC: FDA-registered device maker in Eagan, MN, United States, 4 510(k) clearances

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

Abmrc LLC is registered with the FDA (registration 3016774528) in Eagan, MN, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 24, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016774528
Address: 860 Blue Gentian Road Suite 200, Eagan, MN, United States, 55121
Owner or operator: ABMRC LLC (10071982)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: April 25, 2020
Registered through: 2026
Brand names listed: BiWaze Clear Dual Lumen Breathing Circuit - Acute, BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Large, BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Medium, BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Small, BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Child, BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Infant, BiWaze Clear Dual Lumen Breathing Circuit With Mouthpiece, BiWaze Clear Dual Lumen Breathing Circuit With Trach Adapter and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Positive Pressure Breathing, Intermittent	NHJ	2	Complaint file establishment, Manufacturer, Specification developer	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
August 24, 2026	K260604	BiWaze Clear System	NHJ	Substantially Equivalent	Abmrc, LLC	accessdata.fda.gov
April 8, 2024	K231728	BiWaze Clear System	NHJ	Substantially Equivalent	Abmrc, LLC	accessdata.fda.gov
December 21, 2022	K213564	BiWaze Clear System	NHJ	Substantially Equivalent	Abmrc, LLC	accessdata.fda.gov
March 27, 2020	K191912	BiWaze Cough	NHJ	Substantially Equivalent	Abmrc, LLC	accessdata.fda.gov

Compare with other makers

All makers of Device, Positive Pressure Breathing, Intermittent

Updated August 24, 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.