Cap, Tamper Proof Plastic
FDA 510(k) K782113 · Acacia, Inc.
510(k) numberK782113
Submission
- Device name
- Cap, Tamper Proof Plastic
- Applicant
- Acacia, Inc.
Mchenry, IL, US - Received
- December 19, 1978
- Decision date
- June 1, 1979
- 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 |
|---|---|---|
| K142527 | Extension Set with BD Q-Syte Luer Access Split SeptumFPA · Traditional | 09/19/2014SE |
| K122449 | Enteral Nutrition WarmerLGZ · Traditional | 06/13/2013SE |
| K111381 | Medi-Sis Syringe Infusion SystemLZH · Traditional | 01/13/2012SE |
| K103165 | Blood Sampling SetFPA · Traditional | 11/10/2010SE |
| K092986 | Acacia Piston SyringeFMF · Traditional | 10/27/2009SE |
| K972538 | Flow-Eze Blunt Cannula (1999BC)FMI · Traditional | 07/15/1998SE |
| K931095 | Spring Loaded SyringeFMF · Traditional | 09/16/1993SE |
| K912771 | Acacias Pharm/PumpLHI · Traditional | 02/14/1992SE |
| K901063 | Luer Lock Transfer PinLHI · Traditional | 07/06/1990SE |
| K896990 | PharmulatorLHI · Traditional | 03/23/1990SE |
Questions and answers
When was Cap, Tamper Proof Plastic cleared by the FDA?
Cap, Tamper Proof Plastic (K782113) received a 510(k) decision of Substantially Equivalent on June 1, 1979, 164 days after the submission was received.
What is the product code of K782113?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.