Empty Solution Transfer Container W/ Detach Leg
FDA 510(k) K923448 · Healthtek, Inc.
510(k) numberK923448
Submission
- Device name
- Empty Solution Transfer Container W/ Detach Leg
- Applicant
- Healthtek, Inc.
Auburn, CA, US - Received
- July 14, 1992
- Decision date
- July 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
|---|---|---|
| K913985 | Transfer-Aid(Tm)LHI · Traditional | 03/18/1992SE |
| K913608 | SnapperKPE · Traditional | 11/29/1991SE |
| K881590 | Adfuse(Tm)FRN · Traditional | 05/23/1988SE |
| K874495 | Adcomp 4000 HP SystemLHI · Traditional | 02/16/1988SE |
| K873848 | Retrobulbar NeedleGDM · Traditional | 10/23/1987SE |
| K860610 | AdcompLHI · Traditional | 07/08/1986SE |
| K860372 | Fast Flow XX (Aqueous Solution Filter)FPB · Traditional | 05/30/1986SE |
| K854008 | StatlockLHI · Traditional | 11/13/1985SE |
Questions and answers
When was Empty Solution Transfer Container W/ Detach Leg cleared by the FDA?
Empty Solution Transfer Container W/ Detach Leg (K923448) received a 510(k) decision of Substantially Equivalent on July 28, 1993, 379 days after the submission was received.
What is the product code of K923448?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.