510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111034Substantially Equivalent

Am USA 0.9% Sodium Chloride Flush Syringe

Am USA, Nashville TN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111034 is the FDA 510(k) clearance record for AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE, a class II device, cleared for Am USA 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 4 510(k) clearances for Am USA, from to . As of , FDA records show 2 recalls naming K111034.

Clearance record

Decision date
Received
(92 days to decision)
Product code
NGT Saline, Vascular Access Flush
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Am USA 5209 Lindbar Dr., Nashville TN
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