IV Administration Set Fpa
FDA 510(k) K944208 · Medex, Inc.
510(k) numberK944208
Submission
- Device name
- IV Administration Set Fpa
- Applicant
- Medex, Inc.
Hilliard, OH, US - Received
- August 29, 1994
- Decision date
- December 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | 04/29/2025SE |
| K203738 | QitexioFMF · Traditional | 03/14/2022SE |
| K042432 | Pharmguard Toolbox, Model G6000782FRN · Traditional | 01/04/2005SE |
| K040899 | Medex 3000 Series MR Syringe Infusion PumpFRN · Traditional | 04/30/2004SE |
| K020780 | Transtar Intracranial Pressure Transducer, Model MX950ICPGWM · Abbreviated | 05/20/2002SE |
| K000328 | Medex 3000 Series MRI Compatible Syringe Infusion PumpFRN · Traditional | 05/09/2000SE |
| K982640 | Medex 3000 Series Syringe Infusion PumpFRN · Traditional | 04/06/1999ST |
| K982123 | Contrast Control DeviceFPA · Traditional | 07/21/1998SE |
| K955231 | Medfusion Model 2001 Syringe Infusion PumpFRN · Traditional | 07/18/1996ST |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | 06/27/1996SE |
Questions and answers
When was IV Administration Set Fpa cleared by the FDA?
IV Administration Set Fpa (K944208) received a 510(k) decision of Substantially Equivalent on December 13, 1994, 106 days after the submission was received.
What is the product code of K944208?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.