Data / Medical devices / Monitor, Esophageal Motility, Anorectal Motility, And Tube
Monitor, Esophageal Motility, Anorectal Motility, And Tube (KLA): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA, Class 2, 21 CFR 876.1725). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on February 12, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KLA
- Device class
- 2
- Regulation
- 876.1725
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Italy | 2 |
| United Kingdom | 1 |
| Canada | 1 |
Makers of Monitor, Esophageal Motility, Anorectal Motility, And Tube
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medspira LLC | Minneapolis, MN, United States | Manufacturer | 2 | July 7, 2015 | 0 | 0 | 0 | api.fda.gov |
| THD SPA | Correggio Reggio Emilia, Italy | Manufacturer | 2 | March 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Complaint file establishment, Manufacturer | 1 | April 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Meridian Medical Limited | Littlehampton West Sussex, United Kingdom | Manufacturer, Repackager or relabeler | 1 | January 16, 2004 | 0 | 0 | 0 | api.fda.gov |
| Mui Scientific | MISSISSAUGA Ontario, Canada | Manufacturer | 1 | May 17, 1999 | 0 | 0 | 0 | api.fda.gov |
| Neuraxis, Inc | Carmel, IN, United States | Complaint file establishment, Specification developer | 1 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| BIOMERICS Advanced Catheter | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Custom Solutions | Rochester, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microlab Elettronica | Ponte S. Nicolo Padova, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnesota Medtec, Inc. | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resolution Medical | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rose Medical | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 12, 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.