510(k) Report

FDA applicant

Medspira, LLC

Minneapolis, MN3 decisions2012–20251 recall

FDA records 3 decisions for Medspira, LLC (Minneapolis, MN) from 2012 to 2025: 3 510(k) clearances. Most are in product codes KLA (Monitor, Esophageal Motility, Anorectal…) and FFX (System, Gastrointestinal Motility (Electrical)). Its devices cite 6 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Medspira, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12015: 12025: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2012high 1 (2017) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Medspira, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medspira, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2decisions
  • FFXSystem, Gastrointestinal Motility (Electrical)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 20123cite it
  • K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 20151cites it

What has FDA decided for it lately?

  • K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025
  • K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 20151 recall
  • K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 20121 recall

All 3 as Medspira, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K120088mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System…Jun 14, 2017Class II