I.V. Administration Set with Mini-Spike
FDA 510(k) K780551 · National Patent Development Corp.
510(k) numberK780551
Submission
- Device name
- I.V. Administration Set with Mini-Spike
- Applicant
- National Patent Development Corp.
Mchenry, IL, US - Received
- April 5, 1978
- Decision date
- April 19, 1978
- 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
Other 510(k)s with product code FPA
| 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 |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843974 | Variable Temperature Cautery DeviceGEI · Traditional | 02/26/1985SE |
| K832699 | Hydron Wound Dressing Fast Seat KitFRO · Traditional | 04/27/1984SE |
| K822793 | Pio Root Canal IndicatorEIL · Traditional | 10/22/1982SE |
| K820028 | Zeon Composite Resin Light Cure SysEBF · Traditional | 03/11/1982SE |
| K820006 | Zeon Composite Resin SystemEBF · Traditional | 01/22/1982SE |
| K811446 | Hydron Wound Dressing KitKMF · Traditional | 06/12/1981SE |
| K801484 | Root Canal Filling Applicator NeedlesEIC · Traditional | 07/21/1980SE |
| K801483 | Mark IV SyringeEIC · Traditional | 07/21/1980SE |
| K801482 | Hydron Root Canal Filling MaterialKIF · Traditional | 07/21/1980SE |
| K792136 | Hypo-Allergenic Plastic TapeFPX · Traditional | 01/16/1980SE |
Questions and answers
When was I.V. Administration Set with Mini-Spike cleared by the FDA?
I.V. Administration Set with Mini-Spike (K780551) received a 510(k) decision of Substantially Equivalent on April 19, 1978, 14 days after the submission was received.
What is the product code of K780551?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.