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Sign in to claim this brandNephron Pharmaceuticals Corp.
US
Last updated May 23, 2026
What Nephron Pharmaceuticals Corp. makes
Nephron Pharmaceuticals Corp. manufactures sterile inhalation therapy saline solutions, including isotonic (0.9%) and hypertonic (3%, 7%, and 10%) formulations. These products are designed for respiratory treatments, delivered via inhalation devices to help manage conditions such as cystic fibrosis or chronic obstructive pulmonary disease.
The company’s portfolio is classified under FDA’s Class II medical devices and is authorised through 510(k) premarket notifications and listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Nephron Pharmaceuticals Corp. manufacture?
Nephron Pharmaceuticals Corp. specializes in sterile inhalation therapy saline solutions. These include isotonic formulations (0.9% sodium chloride) and hypertonic formulations (3%, 7%, and 10% sodium chloride). These products are intended for respiratory treatments, typically administered via inhalation devices to help manage conditions like cystic fibrosis or chronic obstructive pulmonary disease.
Where is Nephron Pharmaceuticals Corp. based?
Nephron Pharmaceuticals Corp. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
How are Nephron Pharmaceuticals Corp.’s devices classified by regulatory authorities?
Nephron Pharmaceuticals Corp.’s devices fall under the FDA’s Class II medical device classification. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as premarket notifications (510(k)) to demonstrate substantial equivalence to a predicate device.
Which regulatory registries or databases list Nephron Pharmaceuticals Corp.’s devices?
Nephron Pharmaceuticals Corp.’s devices are authorised through FDA 510(k) premarket notifications and are also listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring traceability and regulatory compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sodium Chloride Inhalation Solution, USP 0.9% | 930103 | FDA UDI | Class II | Active |
| Sodium Chloride Inhalation Solution, USP 3% | 900330 | FDA UDI | Class II | Active |
| Sodium Chloride Inhalation Solution, USP 7% | 900730 | FDA UDI | Class II | Active |
| Sodium Chloride Inhalation Solution, USP 0.9% | 930201 | FDA UDI | Class II | Unknown |
| Sodium Chloride Inhalation Solution, USP 0.9% | 930133 | FDA UDI | Class II | Active |
| Sodium Chloride Inhalation Solution, 3%, 7%, And 10%, Usp-4ml | K120051 | FDA 510(k) | Class II | Active |
| Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | K223559 | FDA 510(k) | Class I | Active |
| Sodium Chlorde Inhalation Solution, 0.9% Usp-3ml | K113033 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Nephron Pharmaceuticals Corp. has five FDA recall records initiated between April 30, 2013, and November 16, 2015, all of which are marked as terminated. The reasons cited include a lack of assurance of sterility due to internal dye ingress test failures affecting vial integrity and a potential dislodgement of the 'Plate A,' which could pose a choking hazard.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 16, 2015 | Z-2053-2016 | — | terminated | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. |
| Nov 16, 2015 | Z-2054-2016 | — | terminated | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. |
| Apr 30, 2013 | Z-1373-2013 | — | terminated | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| Apr 30, 2013 | Z-1371-2013 | — | terminated | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| Apr 30, 2013 | Z-1372-2013 | — | terminated | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |