Data / Medical devices / United States / Nephron SC, LLC.
Nephron SC, LLC.: FDA-registered device maker in West Columbia, SC, United States, 2 510(k) clearances
Nephron SC, LLC. is registered with the FDA (registration 3010892830) in West Columbia, SC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 19, 2012. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010892830
- Address
- 4500 12TH Street Ext, West Columbia, SC, United States, 29172
- Owner or operator
- Nephron SC, LLC. (10052964)
- Roles
- Manufacturer
- First device listed
- October 20, 2016
- Registered through
- 2026
- Brand names listed
- Sodium Chloride Inhalation Solution, USP 0.9%, Sodium Chloride Inhalation Solution, USP 3%, 7%, and 10%
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | 2 | 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 |
|---|---|---|---|---|---|---|
| June 19, 2012 | K113033 | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML | CAF | Substantially Equivalent | Nephron Pharmaceuticals Corp. | accessdata.fda.gov |
| April 20, 2012 | K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML | CAF | Substantially Equivalent | Nephron Pharmaceuticals Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 16, 2015 | 73395 | Class II | Terminated | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for inductio | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. | accessdata.fda.gov |
| April 30, 2013 | 65070 | Class I | Terminated | EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage. | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. | accessdata.fda.gov |
Compare with other makers
Updated June 27, 2016. 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.