510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K926123Substantially Equivalent

Dual Chamber Mixing Bag

Secure Medical, Inc., Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926123 is the FDA 510(k) clearance record for DUAL CHAMBER MIXING BAG, a class II device, cleared for Secure Medical, Inc. on under FDA product code KPE (Container, I.V.). FDA records list one 510(k) clearance for Secure Medical, Inc. As of , FDA records show one recall naming K926123.

Clearance record

Decision date
Received
(273 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Secure Medical, Inc. 1000 Allanson Rd., Mundelein IL
510(k) summary
Statement
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