I.V. Set with and Without Air Vent
FDA 510(k) K860952 · Migada, Ltd.
510(k) numberK860952
Submission
- Device name
- I.V. Set with and Without Air Vent
- Applicant
- Migada, Ltd.
Israel, IL - Received
- March 13, 1986
- Decision date
- August 27, 1986
- 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 |
|---|---|---|
| K954883 | Free Flow Safety DeviceFPA · Traditional | 04/23/1996SE |
| K943095 | IV Transfer SpikeLHI · Traditional | 09/30/1994SE |
| K933929 | Lab-Site(R) Safety CannulaCBF · Traditional | 12/07/1993SE |
| K902881 | Lab-Site Safety NeedleCBT · Traditional | 09/26/1990SE |
| K870016 | Arterial Blood Gassing Monitoring System (Abg)DTB · Traditional | 05/28/1987SE |
| K864453 | Emergency & Military Infusion SystemFPA · Traditional | 01/20/1987SE |
| K863304 | Preselected Flow Rate I.V. SetFPA · Traditional | 12/09/1986SE |
| K861275 | High Flow I.V. SetFPA · Traditional | 06/02/1986SE |
| K860595 | Transfer SetLHI · Traditional | 04/07/1986SE |
| K860605 | Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic FilterFPA · Traditional | 03/24/1986SE |
Questions and answers
When was I.V. Set with and Without Air Vent cleared by the FDA?
I.V. Set with and Without Air Vent (K860952) received a 510(k) decision of Substantially Equivalent on August 27, 1986, 167 days after the submission was received.
What is the product code of K860952?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.