KPE · Container, I.V.
General Hospital · 21 CFR 880.5025 · Class 2
Overview
| Product Code | KPE |
|---|---|
| Device Name | Container, I.V. |
| Regulation | 21 CFR 880.5025 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 117)
Showing 20 most recent of 117 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252079 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | Apr 2, 2026 | SESE |
| K251980 | ClaveQS Bag | Icu Medical, Inc. | Mar 20, 2026 | SESE |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | Jan 9, 2026 | SESE |
| K252094 | eZSURE Empty Fluid Container | Epic Medical Pte. , Ltd. | Aug 1, 2025 | SESE |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | Technoflex Sas. | Apr 18, 2025 | SESE |
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site | Epic Medical Pte. , Ltd. | Jun 21, 2024 | SESE |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte. , Ltd. | Sep 1, 2023 | SESE |
| K222622 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | Feb 16, 2023 | SESE |
| K210749 | Empty EVA Bag | Haemotronic S.P.A. | Aug 19, 2021 | SESE |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | May 6, 2021 | SESE |
| K193528 | Empty EVA Bag | Haemotronic S.P.A. | Jul 22, 2020 | SESE |
| K190328 | HCT Empty EVA Container Pack | Health Care Technologies | Aug 15, 2019 | SESE |
| K190305 | Additive Cap | International Medical Industries, Inc. | Apr 30, 2019 | SESE |
| K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP | Valmed S.R.L. | Feb 15, 2019 | SESE |
| K132276 | STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML | Hospira, Inc. | Nov 12, 2013 | SESE |
| K121161 | EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER | Acta Medical, LLC | Jul 13, 2012 | SESE |
| K111217 | ADDITIVE CAP | Baxter Healthcare Corp | Jun 14, 2011 | SESE |
| K101412 | EVA TPN BAG | Valmed S.R.L. | Apr 13, 2011 | SESE |
| K090096 | ALL-IN-ONE CONTAINER | Baxter Healthcare Corporation | Jan 30, 2009 | SESE |
| K073538 | DUAL CHAMBER TPN CONTAINER | B.Braun Medical, Inc. | Mar 12, 2008 | SESE |
Top Applicants
- Baxter Healthcare Corp — 7 clearances
- Abbott Laboratories — 6 clearances
- Baxa Corp., Sub. of Cook Group, Inc. — 5 clearances
- Gil-Med Industries C/O Kegan & Kegan, Ltd. — 4 clearances
- Medi-Plast Intl., Inc. — 4 clearances
