Additive Cap
FDA 510(k) K190305 · International Medical Industries, Inc.
510(k) numberK190305
Submission
- Device name
- Additive Cap
- Applicant
- International Medical Industries, Inc.
Pompano Beach, FL, US - Received
- February 12, 2019
- Decision date
- April 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
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| K251980 | ClaveQS BagKPE · Traditional | Icu Medical, Inc. | 03/20/2026SE |
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| 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 |
|---|---|---|
| K231095 | Tamper Evident CapFMF · Traditional | 09/04/2024SE |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip CapsQEH · Traditional | 12/16/2020SE |
| K193192 | Tamper Evident CapFMF · Special | 01/31/2020SE |
| K182545 | Tamper Evident Cap with Male Luer LockFPA · Traditional | 01/11/2019SE |
| K173577 | Guarded Luer ConnectorLHI · Traditional | 06/07/2018SE |
| K170672 | Tamper Evident Cap For use with ENFit SyringesPNR · Traditional | 10/06/2017SE |
Questions and answers
When was Additive Cap cleared by the FDA?
Additive Cap (K190305) received a 510(k) decision of Substantially Equivalent on April 30, 2019, 77 days after the submission was received.
What is the product code of K190305?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.