Registered with FDA
InfuSystem Inc.
Lenexa, KS, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What InfuSystem Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Cooling DeviceQUA · Class 2 | — | Lister | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
InfuSystem Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Chemo Mouthpiece, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Jan 2024 | K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | QUA Intraoral Cooling Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| InfuSystem Inc.FDA reg. 3004906872 | Lenexa, KS, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029405). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.