Bag Spigot
FDA 510(k) K910673 · Procedure Products, Inc.
510(k) numberK910673
Submission
- Device name
- Bag Spigot
- Applicant
- Procedure Products, Inc.
Vancouver, WA, US - Received
- February 15, 1991
- Decision date
- April 24, 1991
- 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
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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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K161812 | Freedom SyringeFMF · Abbreviated | 03/27/2017SE |
| K923194 | Insufflator Connecting FilterHIF · Traditional | 10/08/1993SE |
| K922536 | Torque DeviceDQX · Traditional | 12/10/1992SE |
| K914128 | Connecting SetDQO · Traditional | 11/27/1991SE |
| K884985 | Modified 10CC Syringe Control Ring SetFMF · Traditional | 12/20/1988SE |
| K874747 | 10CC Syringe Control Ring SetFMF · Traditional | 02/04/1988SE |
| K874037 | Angio Waste Fluids Dump BagDQO · Traditional | 01/29/1988SE |
| K853749 | Custom Coronary Manifold KitsDTL · Traditional | 01/13/1986SE |
| K842173 | Disposable StopcocksFMG · Traditional | 09/05/1984SE |
| K833554 | Material Addition Lexan & K-ResinDQO · Traditional | 03/12/1984SE |
Questions and answers
When was Bag Spigot cleared by the FDA?
Bag Spigot (K910673) received a 510(k) decision of Substantially Equivalent on April 24, 1991, 68 days after the submission was received.
What is the product code of K910673?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.