510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060258Substantially Equivalent

Autofuser

Ace Medical Us, LLC, Powell OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060258 is the FDA 510(k) clearance record for AUTOFUSER, a class II device, cleared for Ace Medical Us, LLC on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list 2 510(k) clearances for Ace Medical Us, LLC, from to . As of , FDA records show 46 recalls naming K060258.

Clearance record

Decision date
Received
(118 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Ace Medical Us, LLC 9102 Turfway Bend Dr., Powell OH
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