Acti-Flex Fluid Delivery System or Acti-Flex F D S
FDA 510(k) K001233 · R-Group Intl.
510(k) numberK001233
Submission
- Device name
- Acti-Flex Fluid Delivery System or Acti-Flex F D S
- Applicant
- R-Group Intl.
Gainesville, FL, US - Received
- April 17, 2000
- Decision date
- December 13, 2000
- 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
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 |
|---|---|---|
| K001599 | Acti-Flex IV Administration SetFPA · Traditional | 09/18/2000SE |
| K993777 | Disposable and Reusable Ball and Loop ElectrodesHGI · Traditional | 05/25/2000SE |
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional | 11/28/1995SE |
| K954035 | Acti-Flex Arterial Extension SetCBT · Traditional | 09/25/1995SE |
| K940319 | R-Group International Coiled Low Pressure Extension LineFPA · Traditional | 11/10/1994SE |
| K913267 | R-Group Intl. One Wall Puncture NeedleDRC · Traditional | 06/05/1992SE |
Questions and answers
When was Acti-Flex Fluid Delivery System or Acti-Flex F D S cleared by the FDA?
Acti-Flex Fluid Delivery System or Acti-Flex F D S (K001233) received a 510(k) decision of Substantially Equivalent on December 13, 2000, 240 days after the submission was received.
What is the product code of K001233?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.