KPE
- Product code
- KPE
- Device name
- Container, I.V.
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5025
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 117 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252079 | 2026-04-02 | Beijing L&Z Medical Technology Develop… | Disposable Infusion Bag for Parenteral Nutrition | — |
| K251980 | 2026-03-20 | Icu Medical, Inc. | ClaveQS Bag | FDA |
| K251139 | 2026-01-09 | Fresenius Kabi AG | KabiHelp® Uno; KabiHelp® Advance plus | |
| K252094 | 2025-08-01 | Epic Medical Pte. , Ltd. | eZSURE Empty Fluid Container | |
| K250459 | 2025-04-18 | Technoflex Sas. | DMRX 100ml Empty Container Solution; DMRX 250ml Empt… | |
| K241442 | 2024-06-21 | Epic Medical Pte. , Ltd. | eZSURE Empty Fluid Container with ProSeal Injectio… | FDA |
Official FDA classification page: KPE
Classification and pathway per current FDA publications. Data from openFDA (CC0).