Cleared Traditional

Additive Cap

K190305 · International Medical Industries, Inc. · General Hospital
Apr 2019
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K190305 is an FDA 510(k) clearance for the Additive Cap, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on April 30, 2019, 77 days after receiving the submission on February 12, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number K190305 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2019
Decision Date April 30, 2019
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KPE — Container, I.v.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5025

Similar Devices — KPE Container, I.v.

All 114
KabiHelp? Uno; KabiHelp? Advance plus
K251139 · Fresenius Kabi AG · Jan 2026
eZSURE? Empty Fluid Container
K252094 · Epic Medical Pte. , Ltd. · Aug 2025
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
K250459 · Technoflex Sas. · Apr 2025
eZSURE? Empty Fluid Container with ProSeal? Injection Site
K241442 · Epic Medical Pte. , Ltd. · Jun 2024
eZSURE? Empty Fluid Container (models 426030, 426040, 426110)
K223674 · Epic Medical Pte. , Ltd. · Sep 2023
Disposable Infusion Bag for Parenteral Nutrition
K222622 · Beijing L&Z Medical Technology Development Co., Ltd. · Feb 2023