Mcgaw Fat Emulsion Set
FDA 510(k) K820133 · American Mcgaw
510(k) numberK820133
Submission
- Device name
- Mcgaw Fat Emulsion Set
- Applicant
- American Mcgaw
Mchenry, IL, US - Received
- January 18, 1982
- Decision date
- April 6, 1982
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K853549 | Mcgaw/Drop Watch Flow MonitorFLN · Traditional | 11/12/1985SE |
| K843639 | Add-A-Vial Solution Transfer DeviceLHI · Traditional | 01/14/1985SE |
| K843954 | Mixing ContainerKPE · Traditional | 11/28/1984SE |
| K841729 | Accupro Enteral Feeding PumpFRN · Traditional | 06/01/1984SE |
| K840388 | Pab IV ContainerKPE · Traditional | 03/06/1984SE |
| K840212 | Concentrated Platelet Admin. SetFPA · Traditional | 03/06/1984SE |
| K831716 | Capd - Catheter AdapterFKX · Traditional | 06/24/1983SE |
| K822240 | Ethylene Oxide Steriliz. Parametric Rel.KFX · Traditional | 12/30/1982SE |
| K813092 | Accupro I.V. Administration SetFPA · Traditional | 12/31/1981SE |
| K810683 | Capd Catheter AdapterFKX · Traditional | 05/08/1981SE |
Questions and answers
When was Mcgaw Fat Emulsion Set cleared by the FDA?
Mcgaw Fat Emulsion Set (K820133) received a 510(k) decision of Substantially Equivalent on April 6, 1982, 78 days after the submission was received.
What is the product code of K820133?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.