Luer-Lok Multiflo Adapter
FDA 510(k) K882797 · Deseret Medical, Inc.
510(k) numberK882797
Submission
- Device name
- Luer-Lok Multiflo Adapter
- Applicant
- Deseret Medical, Inc.
Sandy, UT, US - Received
- July 6, 1988
- Decision date
- July 18, 1988
- 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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| 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 |
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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 |
|---|---|---|
| K913027 | Vessel DilatorDRE · Traditional | 11/27/1991SE |
| K904648 | Safe Syte I.V. Catheter Placement UnitFOZ · Traditional | 12/14/1990SE |
| K904121 | Vialon ObturatorFOZ · Traditional | 11/08/1990SE |
| K904122 | Insyte-A Arterial Catheterization UnitFOZ · Traditional | 10/04/1990SE |
| K900116 | Deseret Optima Intravascular CatheterFOZ · Traditional | 06/18/1990SE |
| K895735 | Deseret Multilumen Subclavian CatheterLYY · Traditional | 05/18/1990SE |
| K895734 | Deseret Intravascular CatheterFOZ · Traditional | 04/09/1990SE |
| K894033 | Disposable Catheter Pressure TransducerDXO · Traditional | 10/17/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | 06/22/1989SE |
| K882798 | Multiflo AdapterFPA · Traditional | 07/18/1988SE |
Questions and answers
When was Luer-Lok Multiflo Adapter cleared by the FDA?
Luer-Lok Multiflo Adapter (K882797) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 12 days after the submission was received.
What is the product code of K882797?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.