Shrouded Needle Devices
FDA 510(k) K924718 · Imed Corp.
510(k) numberK924718
Submission
- Device name
- Shrouded Needle Devices
- Applicant
- Imed Corp.
San Diego, CA, US - Received
- September 21, 1992
- Decision date
- June 18, 1993
- 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 |
|---|---|---|
| K960512 | Gemini Pc-ItxFRN · Traditional | 11/21/1996SE |
| K953896 | The Imed Ambulatory Infusion Pump, Administration SetsFRN · Traditional | 03/20/1996SE |
| K950153 | Vented/Nonvented Gemini Administration Set with Check Valve and Two Safsite(Tm) ValvesFPA · Traditional | 08/24/1995SE |
| K951922 | Administration Sets with Ball FloatFPA · Traditional | 07/19/1995SE |
| K950419 | The Imed Orion Infusion Pump and Administration SetsFRN · Traditional | 06/21/1995SE |
| K944320 | Vented/Non-Vented Gemini Administration SetFPA · Traditional | 02/14/1995SE |
| K945070 | Versasae Plastic Cannula- 11 GaugeFPA · Traditional | 01/13/1995SE |
| K931173 | Primary Admin Set W/Univ Sp-Man Below/Abv Pump CHFPA · Traditional | 04/15/1994SE |
| K933144 | Gemini Volumetric Infusion Pump/ControllerFRN · Traditional | 10/12/1993SE |
| K921378 | Imed Model PC-4 Volumetric Infusion Pump/ControlleFRN · Traditional | 06/09/1992SE |
Questions and answers
When was Shrouded Needle Devices cleared by the FDA?
Shrouded Needle Devices (K924718) received a 510(k) decision of Substantially Equivalent on June 18, 1993, 270 days after the submission was received.
What is the product code of K924718?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.