KPE — Container, I.V. Class II
FDA product code KPE covers "Container, I.V.", a Class II medical device regulated under 21 CFR 880.5025. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPE
- Device Class
- Class II
- Regulation Number
- 880.5025
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252079 | Beijing L And Z Medical Technology Development Co | Disposable Infusion Bag for Parenteral Nutrition | Apr 2, 2026 |
| K251980 | Icu Medical | ClaveQS Bag | Mar 20, 2026 |
| K251139 | Fresenius Kabi | KabiHelp® Uno; KabiHelp® Advance plus | Jan 9, 2026 |
| K252094 | Epic Medical Pte. | eZSURE Empty Fluid Container | Aug 1, 2025 |
| K250459 | Technoflex | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 5 | Apr 18, 2025 |
| K241442 | Epic Medical Pte. | eZSURE Empty Fluid Container with ProSeal Injection Site | Jun 21, 2024 |
| K223674 | Epic Medical Pte. | eZSURE Empty Fluid Container (models 426030, 426040, 426110) | Sep 1, 2023 |
| K222622 | Beijing L And Z Medical Technology Development Co | Disposable Infusion Bag for Parenteral Nutrition | Feb 16, 2023 |
| K210749 | Haemotronic | Empty EVA Bag | Aug 19, 2021 |
| K201936 | Gilero | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | May 6, 2021 |
| K193528 | Haemotronic | Empty EVA Bag | Jul 22, 2020 |
| K190328 | Health Care Technologies | HCT Empty EVA Container Pack | Aug 15, 2019 |
| K190305 | International Medical Industries | Additive Cap | Apr 30, 2019 |
| K181393 | Valmed | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM | Feb 15, 2019 |
| K132276 | Hospira | STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STE | Nov 12, 2013 |
| K121161 | Acta Medical | EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER | Jul 13, 2012 |
| K111217 | Baxter Healthcare | ADDITIVE CAP | Jun 14, 2011 |
| K101412 | Valmed | EVA TPN BAG | Apr 13, 2011 |
| K090096 | Baxter Healthcare Corporation | ALL-IN-ONE CONTAINER | Jan 30, 2009 |
| K073538 | B.Braun Medical | DUAL CHAMBER TPN CONTAINER | Mar 12, 2008 |