510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121161Substantially Equivalent

Empty Eva Solution Container Empty Eva Dual Chamber Solution Container

Acta Medical L.L.C., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121161 is the FDA 510(k) clearance record for EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER, a class II device, cleared for Acta Medical, LLC on under FDA product code KPE (Container, I.V.). FDA records list 3 510(k) clearances for Acta Medical, LLC, from to . As of , FDA records show no recalls naming K121161.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Acta Medical, LLC 929 Arbor Downs Sr, Plano TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPE

Trailing 12 months
3 clearances under product code KPE in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260