Data / Medical devices / United States / The Ritedose Corporation
The Ritedose Corporation: FDA-registered device maker in Columbia, SC, United States, 4 510(k) clearances
The Ritedose Corporation is registered with the FDA (registration 1063407) in Columbia, SC, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated December 3, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1063407
- FEI number
- 3001237796
- Address
- 1 Technology Cir, Columbia, SC, United States, 29203
- Owner or operator
- The Ritedose Corporation (9030287)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 20, 2007
- Registered through
- 2027
- Brand names listed
- Hyper Sal, Sodium Chloride Inhalation Solution, 10%, Sodium Chloride Inhalation Solution, 3%, Sodium Chloride Inhalation Solution, 3.5%, Sodium Chloride Inhalation Solution, 7%, Sodium Chloride Inhalation Solution, USP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 3, 2021 | K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | CAF | Substantially Equivalent | The Ritedose Corporation | accessdata.fda.gov |
| January 21, 1998 | K974056 | 0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP | CAF | Substantially Equivalent | Holopack International, LP | accessdata.fda.gov |
| August 28, 1997 | K972467 | STERILE WATER FOR INHALATION, USP | CAF | Substantially Equivalent | Holopack International, LP | accessdata.fda.gov |
| August 28, 1997 | K972466 | SODIUM CHLORIDE INHALATION SOLUTION, USP | CAF | Substantially Equivalent | Holopack International, LP | accessdata.fda.gov |
Compare with other makers
Updated December 3, 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.