Data / Medical devices / United States / Grumpy Innovation Inc
Grumpy Innovation Inc: FDA-registered device maker in Sioux Falls, SD, United States, 1 510(k) clearance
Grumpy Innovation Inc is registered with the FDA (registration 3044675089) in Sioux Falls, SD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044675089
- Address
- 100 E 6th St, Sioux Falls, SD, United States, 57104
- Owner or operator
- Grumpy Innovation Inc (10095709)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 16, 2026
- Registered through
- 2026
- Brand names listed
- Portare System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 5, 2025 | K243639 | Portare System (FA-001) | EOB | Substantially Equivalent | Grumpy Innovation, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 5, 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.