PVC Empty Solution Container W/3 Lead Transfer Set
FDA 510(k) K890095 · Kells Medical, Inc.
510(k) numberK890095
Submission
- Device name
- PVC Empty Solution Container W/3 Lead Transfer Set
- Applicant
- Kells Medical, Inc.
Redlands, CA, US - Received
- January 10, 1989
- Decision date
- May 24, 1989
- 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 |
More from Gilero, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K926333 | CPR PlusLIX · Traditional | 11/08/1993SE |
| K890093 | PVC Empty Solution Container Enteral Pump SetKNT · Traditional | 07/24/1989SE |
| K890094 | Eva Empty Solution Container W/3 Lead Transfer SetKPE · Traditional | 05/24/1989SE |
| K861972 | DermistripNAD · Traditional | 06/27/1986SN |
| K844463 | DermidressKGX · Traditional | 01/08/1985SE |
| K844072 | Dermizip Skin Closure Device · Traditional | 11/05/1984SE |
| K832678 | Phonatory Function Analyzer PS-77BXP · Traditional | 03/07/1984SE |
| K832667 | Lucae's Ear & Nasal ApplicatorsKCJ · Traditional | 09/29/1983SE |
| K823118 | SayESE · Traditional | 01/07/1983SE |
| K823227 | Impedance Meter ON-1ETY · Traditional | 11/22/1982SE |
Questions and answers
When was PVC Empty Solution Container W/3 Lead Transfer Set cleared by the FDA?
PVC Empty Solution Container W/3 Lead Transfer Set (K890095) received a 510(k) decision of Substantially Equivalent on May 24, 1989, 134 days after the submission was received.
What is the product code of K890095?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.