Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
FDA 510(k) K001287 · Sorenson Medical, Inc.
510(k) numberK001287
Submission
- Device name
- Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
- Applicant
- Sorenson Medical, Inc.
West Jordan, UT, US - Received
- April 24, 2000
- Decision date
- June 9, 2000
- 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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| K251980 | ClaveQS BagKPE · Traditional | Icu Medical, Inc. | 03/20/2026SE |
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| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…KPE · Traditional | Technoflex Sas. | 04/18/2025SE |
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| 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 |
|---|---|---|
| K052221 | Ambit Push & Play Ambulatory Infusion PumpFRN · Abbreviated | 12/08/2005SE |
| K033425 | Ambit Intermittent Ambulatory Infusion PumpFRN · Special | 11/06/2003SE |
| K033325 | Ambit Continuous Ambulatory Infusion PumpFRN · Special | 11/06/2003SE |
| K002434 | Palm PumpMEA · Special | 08/23/2000SE |
| K991363 | 30 Pump, Continuous Low Flow, 200 Pump, Intermittent with Kvo or Continuous, Pca Pump…FRN · Special | 05/13/1999SE |
Questions and answers
When was Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML cleared by the FDA?
Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML (K001287) received a 510(k) decision of Substantially Equivalent on June 9, 2000, 46 days after the submission was received.
What is the product code of K001287?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.