510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medspira, LLC

Minneapolis, MN, US

MEDSPIRA LLC appears in FDA device records in Minneapolis, MN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Medspira, LLC between 2012 and 2025. The busiest year on record is 2012, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medspira, LLC, by decision year
YearClearances
20121
20151
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)FFXSubstantially Equivalent
K143031mcompass Biofeedback Anorectal Manometry SystemKLASubstantially Equivalent
K120088MCOMPASS ANORECTAL MANOMETRY SYSTEMKLASubstantially Equivalent

Registered establishments

FDA registered establishments for Medspira, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30084146213008414621MEDSPIRA LLC2718 Summer St NE, Minneapolis, MN 55413 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3072-2017mcompass 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 component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain