Nephron SC, LLC.
West Columbia, SC, US
NEPHRON SC, LLC. appears in FDA device records in West Columbia, SC. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Nephron SC, LLC. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Nephron Pharmaceuticals Corporation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 3 510(k) clearances for Nephron SC, LLC. between 2012 and 2023. The busiest year on record is 2012, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | LZA | Substantially Equivalent | |
| K113033 | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML | CAF | Substantially Equivalent | |
| K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML | CAF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010892830 | 3010892830 | NEPHRON SC, LLC. | 4500 12TH STREET EXT, West Columbia, SC 29172 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2054-2016 | Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. | Class II | Terminated | |
| Z-2053-2016 | 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 induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. | Class II | Terminated | |
| Z-1373-2013 | EZ Breathe Medication Cup. 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. | Class I | Terminated | |
| Z-1372-2013 | AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. 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. | Class I | Terminated | |
| Z-1371-2013 | 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. | Class I | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Nephron SC, LLC. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain