Fluid Administration Line W/Spike 14-923
FDA 510(k) K842858 · Norton Performance Plastics Corp.
510(k) numberK842858
Submission
- Device name
- Fluid Administration Line W/Spike 14-923
- Applicant
- Norton Performance Plastics Corp.
Mchenry, IL, US - Received
- July 23, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853791 | Norton Cardioplegic Quick Cooling Coil 421738-000DTR · Traditional | 12/09/1985SE |
| K852914 | Angiographic, Wedge Press, Dual Thermod & InfusionDQY · Traditional | 09/25/1985SE |
| K851299 | Correct FloFPA · Traditional | 05/07/1985SE |
| K841828 | Central Venous Catheter W/Big-GardDQY · Traditional | 07/13/1984SE |
| K840240 | Microfuse Intravenous Catheter SetDQY · Traditional | 04/17/1984SE |
| K831587 | Temp. Repair Kit-Dual Lumen CatheterLJS · Traditional | 10/19/1983SE |
| K831698 | Disposable Pressure TRANSDUCER#14004195DRS · Traditional | 08/11/1983SE |
| K830788 | Central Vein Catherization KIT-14-690-DQO · Traditional | 04/30/1983SE |
| K830813 | French Percutaneous Sheath IntroducerDYB · Traditional | 04/28/1983SE |
| K830969 | Perm. Repair Kit for Leonard Norton DualLJS · Traditional | 04/14/1983SE |
Questions and answers
When was Fluid Administration Line W/Spike 14-923 cleared by the FDA?
Fluid Administration Line W/Spike 14-923 (K842858) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 50 days after the submission was received.
What is the product code of K842858?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.