510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963722Substantially Equivalent

IV Start Kit

Grand Medical Products, Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963722 is the FDA 510(k) clearance record for IV START KIT, a class II device, cleared for Grand Medical Products on under FDA product code LRS (I.V. Start Kit). FDA's definition for product code LRS reads: "This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at...". FDA records list 8 510(k) clearances for Grand Medical Products, from to . As of , FDA records show no recalls naming K963722.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LRS I.V. Start Kit
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Grand Medical Products 1300 Remington Rd., Suite K, Schaumburg IL
510(k) summary
Statement
Third party review
No

Clearances, product code LRS

Trailing 12 months

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

FDA records show no clearances under product code LRS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRS, 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