510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K023098Substantially Equivalent

Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit

Mckinley Infuser, San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023098 is the FDA 510(k) clearance record for ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT, a class II device, cleared for Mckinley Infuser on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list one 510(k) clearance for Mckinley Infuser. As of , FDA records show no recalls naming K023098.

Clearance record

Decision date
Received
(82 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Mckinley Infuser 631 Howard #202, San Francisco CA
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