510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934543Substantially Equivalent

Universal Controller, Model 100

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

K934543 is the FDA 510(k) clearance record for UNIVERSAL CONTROLLER, MODEL 100, a class II device, cleared for Metamed, Inc. on under FDA product code LDR (Controller, Infusion, Intravascular, Electronic). FDA records list one 510(k) clearance for Metamed, Inc. As of , FDA records show no recalls naming K934543.

Clearance record

Decision date
Received
(194 days to decision)
Product code
LDR Controller, Infusion, Intravascular, Electronic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Metamed, Inc. 5937 Balboa Ave., Suite 103, San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code LDR

Trailing 12 months

FDA records hold no clearances under product code LDR in the trailing twelve months.

FDA records show no clearances under product code LDR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260