Data / Medical devices / United States / CM Technologies, Inc.
CM Technologies, Inc.: FDA-registered device maker in Carrollton, TX, United States, 2 510(k) clearances
CM Technologies, Inc. is registered with the FDA (registration 3013524793) in Carrollton, TX, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 17, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013524793
- Address
- 1321 Valwood Parkway Suite 530, Carrollton, TX, United States, 75006
- Owner or operator
- CM Technologies, Inc. (10049590)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 22, 2017
- Registered through
- 2026
- Brand names listed
- AUM Canister, AUM Drainage Tubing, QiVi Acute Male External Urine Management Device, QiVi Automated Urine Management Device, QiVi Female External Urine Management Device, QiVi Lite Male External Urine Management Device, QiVi Male External Urine Management Device, Qora Aeon Stool Management Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Paste-On For Incontinence, Non-Sterile | NOA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 17, 2021 | K212444 | Qora Stool Management Kit | KNT | Substantially Equivalent | Cm Technologies, Inc. | accessdata.fda.gov |
| May 6, 2016 | K153506 | Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit | KNT | Substantially Equivalent | Consure Medical Pvt , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Collector, Urine, Powered, Non Indwelling Catheter
- All makers of Bottle, Collection, Vacuum
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Device, Paste-On For Incontinence, Non-Sterile
Updated November 17, 2021. 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.