510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913658Substantially Equivalent

Imed 4100 and 4200 Disposable Infusion Devices Mod

Imed Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913658 is the FDA 510(k) clearance record for IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD, a class II device, cleared for Imed Corp. on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list 24 510(k) clearances for Imed Corp., from to . As of , FDA records show one recall naming K913658.

Clearance record

Decision date
Received
(241 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Imed Corp. 9775 Businesspark Ave., San Diego CA
510(k) summary
Statement
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