Medspira, Llc

FDA Regulatory Profile

Medspira, Llc appears in FDA public data with 1 recall, 3 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3072-2017, Class II) was initiated on June 14, 2017. Its most recent 510(k) clearance was granted on December 5, 2025.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3072-2017Class IImcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for uJune 14, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)December 5, 2025
K143031mcompass Biofeedback Anorectal Manometry SystemJuly 7, 2015
K120088MCOMPASS ANORECTAL MANOMETRY SYSTEMMarch 29, 2012