510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K050770Substantially Equivalent

Modification to Accufuser, Accufuser Plus Standard Procedure Kit

Mckinley Medical, LLC, Wheat Ridge CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050770 is the FDA 510(k) clearance record for MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT, a class II device, cleared for Mckinley Medical, LLC on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list 2 510(k) clearances for Mckinley Medical, LLC, from to . As of , FDA records show no recalls naming K050770.

Clearance record

Decision date
Received
(20 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Mckinley Medical, LLC 4080 Youngfield, Wheat Ridge CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEB

Trailing 12 months
1 clearance under product code MEB in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260