Data / Medical devices / United States / Aatru Medical, LLC
Aatru Medical, LLC: FDA-registered device maker in Cleveland, OH, United States, 1 510(k) clearance
Aatru Medical, LLC is registered with the FDA (registration 3020964723) in Cleveland, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020964723
- Address
- 1301 East 9th St., Suite 1414, Cleveland, OH, United States, 44114
- Owner or operator
- Aatru Medical, LLC (10072987)
- Roles
- Specification developer
- First device listed
- November 13, 2021
- Registered through
- 2026
- Brand names listed
- npSIMS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical | QPX | 2 | 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 |
|---|---|---|---|---|---|---|
| August 23, 2021 | K201400 | npSIMS Negative Pressure Surgical Incision Management System (npSIMS) | QPX | Substantially Equivalent | Aatru Medical, LLC | accessdata.fda.gov |
Updated August 23, 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.