Correct Flo Intravascular Administration Set
FDA 510(k) K850506 · Biomedical Dynamics, Inc.
510(k) numberK850506
Submission
- Device name
- Correct Flo Intravascular Administration Set
- Applicant
- Biomedical Dynamics, Inc.
Minneapolis, MN, US - Received
- February 8, 1985
- Decision date
- April 1, 1985
- 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 |
|---|---|---|
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | 02/05/1992SE |
| K913751 | Pressure InfuserKZD · Traditional | 01/09/1992SE |
| K911213 | CuffableDXQ · Traditional | 08/07/1991SE |
| K911216 | InfusableKZD · Traditional | 07/22/1991SE |
| K911324 | Irrigation/Aspiration Tubing SetKDH · Traditional | 06/24/1991SE |
| K904376 | Aneroid Blood Pressure GaugeFCY · Traditional | 12/20/1990SE |
| K890268 | Pressure Infusor for I.V. Bags/AutoinflationKPE · Traditional | 05/05/1989SE |
| K881799 | Blood Pressure CuffDXQ · Traditional | 10/14/1988SE |
| K861977 | Biomedical Dynamics Disposable Pressure InfusorKZD · Traditional | 07/15/1986SE |
Questions and answers
When was Correct Flo Intravascular Administration Set cleared by the FDA?
Correct Flo Intravascular Administration Set (K850506) received a 510(k) decision of Substantially Equivalent on April 1, 1985, 52 days after the submission was received.
What is the product code of K850506?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.