510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011283Substantially Equivalent

Monoject Prefill 0.9% Sodium Chloride Flush Syringe

Kendall, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011283 is the FDA 510(k) clearance record for MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, a class II device, cleared for The Kendall Company 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 22 510(k) clearances for The Kendall Company, from to . As of , FDA records show no recalls naming K011283.

Clearance record

Decision date
Received
(171 days to decision)
Product code
NGT Saline, Vascular Access Flush
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
The Kendall Company 15 Hampshire St., Mansfield MA
510(k) summary
Summary
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