510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K103740Substantially Equivalent

Sodium Chloride Injection, 0.9%, Usp 5 Ml, 10 Ml Ampule

Spectra Medical Devices, LLC, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103740 is the FDA 510(k) clearance record for SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE, a class II device, cleared for Spectra Medical Devices, Inc. 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 8 510(k) clearances for Spectra Medical Devices, Inc., from to . As of , FDA records show one recall naming K103740.

Clearance record

Decision date
Received
(219 days to decision)
Product code
NGT Saline, Vascular Access Flush
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Spectra Medical Devices, Inc. 3000 K St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NGT

Trailing 12 months
1 clearance under product code NGT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NGT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260