510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943047Substantially Equivalent

IV Start Kits

Sterile Concepts, Inc., Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943047 is the FDA 510(k) clearance record for IV START KITS, a class I device, cleared for Sterile Concepts, Inc. on under FDA product code KMK (Device, Intravascular Catheter Securement). FDA records list 10 510(k) clearances for Sterile Concepts, Inc., from to . As of , FDA records show no recalls naming K943047.

Clearance record

Decision date
Received
(79 days to decision)
Product code
KMK Device, Intravascular Catheter Securement
Regulation
21 CFR 880.5210
Device class
Class I
Review panel
General Hospital
Applicant
Sterile Concepts, Inc. 5100 Commerce Rd.., Richmond VA
510(k) summary
Summary
Third party review
No

Clearances, product code KMK

Trailing 12 months

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

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