Exel Injection Plug with Cap
FDA 510(k) K992290 · Exel Intl.
510(k) numberK992290
Submission
- Device name
- Exel Injection Plug with Cap
- Applicant
- Exel Intl.
Culver City, CA, US - Received
- July 7, 1999
- Decision date
- February 23, 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
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| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
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| 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 |
|---|---|---|
| K963658 | Exel Avf Single NeedleFMI · Traditional | 05/05/1998SE |
| K963659 | Exel I.V. Administration SetFPA · Traditional | 12/16/1997SE |
| K926119 | Exel Huber Infusion Set Rotating WingFPA · Traditional | 08/11/1993SE |
| K904685 | Exel Huber Infusion Set Without Injection Site (Y)FPA · Traditional | 11/21/1990SE |
| K903945 | Exel A-V Fistula SetFIE · Traditional | 11/20/1990SE |
| K895770 | Exel Huber Infusion SetFPA · Traditional | 07/19/1990SE |
| K895772 | Exel Indwelling CatheterFDZ · Traditional | 02/16/1990SE |
| K895771 | Exel Spinal NeedlesFMI · Traditional | 02/16/1990SE |
| K895769 | Exel Huber NeedleFMI · Traditional | 02/16/1990SE |
| K895768 | Exel Safelet CatheterFOZ · Traditional | 02/16/1990SE |
Questions and answers
When was Exel Injection Plug with Cap cleared by the FDA?
Exel Injection Plug with Cap (K992290) received a 510(k) decision of Substantially Equivalent on February 23, 2000, 231 days after the submission was received.
What is the product code of K992290?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.