0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
K142620 is the FDA 510(k) clearance record for 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe, a class II device, cleared for Excelsior Medical Corporation on under FDA product code NGT (Saline, Vascular Access Flush). FDA's definition for product code NGT reads: "Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use". FDA records list 11 510(k) clearances for Excelsior Medical Corporation, from to . As of , FDA records show one recall naming K142620.
Clearance record
- Decision date
- Received
- (87 days to decision)
- Product code
- NGT Saline, Vascular Access Flush
- Regulation
- 21 CFR 880.5200
- Device class
- Class II
- Review panel
- General Hospital
- Applicant
- Excelsior Medical Corporation 1933 Heck Ave., Neptune NJ
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code NGT
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
