Free Flow Safety Device
FDA 510(k) K954883 · Migada, Inc.
510(k) numberK954883
Submission
- Device name
- Free Flow Safety Device
- Applicant
- Migada, Inc.
Englewood Cliffs, NJ, US - Received
- October 20, 1995
- Decision date
- April 23, 1996
- 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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| 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 |
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| 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 |
|---|---|---|
| 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 |
| K860952 | I.V. Set with and Without Air VentFPA · Traditional | 08/27/1986SE |
| 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 Free Flow Safety Device cleared by the FDA?
Free Flow Safety Device (K954883) received a 510(k) decision of Substantially Equivalent on April 23, 1996, 186 days after the submission was received.
What is the product code of K954883?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.