510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092491Substantially Equivalent

Medefil's Heparin i.v. Flush Syringe 1 Unit/ml; 10 Units/ml; and 100 Units/ml in Various Fill Sizes

Medefil, Inc., Glendale Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092491 is the FDA 510(k) clearance record for MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES, a class II device, cleared for Medefil, Inc. on under FDA product code NZW (Heparin, Vascular Access Flush). FDA's definition for product code NZW reads: "Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use". FDA records list 7 510(k) clearances for Medefil, Inc., from to . As of , FDA records show 4 recalls naming K092491.

Clearance record

Decision date
Received
(174 days to decision)
Product code
NZW Heparin, Vascular Access Flush
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Medefil, Inc. 250 Windy Pt. Dr., Glendale Heights IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZW

Trailing 12 months

FDA records hold no clearances under product code NZW in the trailing twelve months.

FDA records show no clearances under product code NZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260