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Medspira LLC: FDA-registered device maker in Minneapolis, MN, United States, 5 510(k) clearances

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

Medspira LLC is registered with the FDA (registration 3008414621) in Minneapolis, MN, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 5, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008414621
Address: 2718 Summer St NE, Minneapolis, MN, United States, 55413
Owner or operator: MEDSPIRA LLC (10030584)
Roles: Manufacturer
First device listed: October 20, 2009
Registered through: 2026
Brand names listed: Breath Hold, Integrated Breath Hold Control Sys., Medspira BC-10 1.5T, Medspira BC-10 3T, mcompass Anorectal Balloon Expulsion Catheter, mcompass Anorectal Manometry System, mcompass Biofeedback Anorectal Manometry System.

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Manufacturer	accessdata.fda.gov
Device, Biofeedback	HCC	2	Manufacturer	accessdata.fda.gov
Monitor, Esophageal Motility, Anorectal Motility, And Tube	KLA	2	Manufacturer	accessdata.fda.gov
System, Gastrointestinal Motility (Electrical)	FFX	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 5, 2025	K252605	mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)	FFX	Substantially Equivalent	Medspira, LLC	accessdata.fda.gov
July 7, 2015	K143031	mcompass Biofeedback Anorectal Manometry System	KLA	Substantially Equivalent	Medspira, LLC	accessdata.fda.gov
March 29, 2012	K120088	MCOMPASS ANORECTAL MANOMETRY SYSTEM	KLA	Substantially Equivalent	Medspira, LLC	accessdata.fda.gov
April 14, 2004	K040122	MAYO CLINIC BC-10 3.0T	MOS	Substantially Equivalent	Mayo Clinic	accessdata.fda.gov
July 15, 2003	K031119	MAYO CLINIC BC-10 1.5T	MOS	Substantially Equivalent	Mayo Medical Ventures	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 14, 2017	77706	Class II	Terminated	mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB	Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.	accessdata.fda.gov

Compare with other makers

Updated December 5, 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.