SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML— 510(k) K120051
Substantially EquivalentNephron Pharmaceuticals Corp.
FDA 510(k) clearance K120051 for SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML, Substantially Equivalent on 2012-04-20. Applicant: Nephron Pharmaceuticals Corp.. Device class: 2.
Clearance details
- Applicant
- Nephron Pharmaceuticals Corp.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
Recent devices under product code CAF
view allMore clearances from Nephron Pharmaceuticals Corp.
view allAdverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K120051
K-number listed on FDA's recall record- 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
- 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120051.
Data sourced from openFDA. This site is unofficial and independent of the FDA.