S.C.T. Multi Port, Injection Site
FDA 510(k) K864296 · Salt Creek Medical Technologies
510(k) numberK864296
Submission
- Device name
- S.C.T. Multi Port, Injection Site
- Applicant
- Salt Creek Medical Technologies
Canfield, OH, US - Received
- October 31, 1986
- Decision date
- March 2, 1987
- 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 |
|---|---|---|
| K864683 | Neonatal Feeding KitKNT · Traditional | 04/17/1987SE |
| K871042 | Urine Meter, 250CCKNX · Traditional | 03/25/1987SE |
| K871087 | S.C.M.T. PerforatorHGE · Traditional | 03/23/1987SE |
| K871075 | SCMT Umbilical ClampHFW · Traditional | 03/23/1987SE |
| K864682 | Salt Creek P.I. Tray · Traditional | 01/06/1987SE |
| K864692 | Extension SetsFPK · Traditional | 12/18/1986SE |
| K864693 | I.V. Start Kits · Traditional | 12/16/1986SE |
Questions and answers
When was S.C.T. Multi Port, Injection Site cleared by the FDA?
S.C.T. Multi Port, Injection Site (K864296) received a 510(k) decision of Substantially Equivalent on March 2, 1987, 122 days after the submission was received.
What is the product code of K864296?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.