I.V. Bottle (Ridgid)
FDA 510(k) K811234 · Medi-Plast Intl., Inc.
510(k) numberK811234
Submission
- Device name
- I.V. Bottle (Ridgid)
- Applicant
- Medi-Plast Intl., Inc.
Walker, MI, US - Received
- May 4, 1981
- Decision date
- June 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
Other 510(k)s with product code KPE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252079 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 04/02/2026SE |
| K251980 | ClaveQS BagKPE · Traditional | Icu Medical, Inc. | 03/20/2026SE |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional | Fresenius Kabi AG | 01/09/2026SE |
| K252094 | eZSURE Empty Fluid ContainerKPE · Special | Epic Medical Pte. , Ltd. | 08/01/2025SE |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…KPE · Traditional | Technoflex Sas. | 04/18/2025SE |
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection SiteKPE · Special | Epic Medical Pte. , Ltd. | 06/21/2024SE |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110)KPE · Traditional | Epic Medical Pte. , Ltd. | 09/01/2023SE |
| K222622 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 02/16/2023SE |
| K210749 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 08/19/2021SE |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLKPE · Traditional | Gilero, LLC | 05/06/2021SE |
More from Gilero, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K954284 | Medi-Plast 2 Port Manifold (Right on)DTL · Traditional | 02/12/1996SE |
| K873588 | 10CC Control SyringeFMF · Traditional | 10/23/1987SE |
| K863402 | Medi-Plast Disposable ManifoldDTL · Traditional | 10/22/1986SE |
| K861785 | Fluoroscope Band BagJAA · Traditional | 06/13/1986SE |
| K851489 | Arterial-Venous Compression Dressing · Traditional | 06/11/1985SE |
| K842136 | Sterile Pan SetFRG · Traditional | 07/06/1984SE |
| K840021 | Operating Room Tray SetFSM · Traditional | 03/15/1984SE |
| K840022 | Heart Catheterization Tray SetDRE · Traditional | 02/04/1984SE |
| K811268 | Bottle-To-BottleKPE · Traditional | 06/18/1981SE |
| K811233 | I.V. Plastic BagKPE · Traditional | 06/17/1981SE |
Questions and answers
When was I.V. Bottle (Ridgid) cleared by the FDA?
I.V. Bottle (Ridgid) (K811234) received a 510(k) decision of Substantially Equivalent on June 18, 1981, 45 days after the submission was received.
What is the product code of K811234?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.