510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K030889Substantially Equivalent

Ultraekogel Models Ek 2000 & Ek 2001

Inmed Ltda., Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030889 is the FDA 510(k) clearance record for ULTRAEKOGEL MODELS EK 2000 & EK 2001, a class II device, cleared for Inmed Ltda. on under FDA product code MUI (Media, Coupling, Ultrasound). FDA records list 3 510(k) clearances for Inmed Ltda., from to . As of , FDA records show no recalls naming K030889.

Clearance record

Decision date
Received
(63 days to decision)
Product code
MUI Media, Coupling, Ultrasound
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Inmed Ltda. 1308 Morningside Park Dr., Alpharetta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUI

Trailing 12 months
2 clearances under product code MUI 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 MUI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260