Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
FDA 510(k) K162304 · Quest Medical, Inc.
510(k) numberK162304
Submission
- Device name
- Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
- Applicant
- Quest Medical, Inc.
Allen, TX, US - Received
- August 17, 2016
- Decision date
- December 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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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 |
|---|---|---|
| K241058 | Lyka® PORT Needle Free Access Device (4170Y)FPA · Traditional | 12/18/2024SE |
| K213846 | Q2 Blood Administration SetsFPA · Traditional | 06/05/2022SE |
| K213588 | Q2 IV Administration SetsFPA · Traditional | 06/02/2022SE |
| K202672 | Precision Delivery Infusion SetFPA · Traditional | 01/21/2021SE |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | 11/20/2020SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | 06/19/2020SE |
| K182442 | MiniGuard Arterial Safety ValveMJJ · Traditional | 11/06/2018SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | 10/01/2018SE |
| K162804 | Q2 Low Pressure Power Injection Extension SetFPA · Traditional | 03/08/2017SE |
| K151079 | Q2 Intravenous Adminstration Sets and Extension SetsFPA · Traditional | 09/30/2015SE |
Questions and answers
When was Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets cleared by the FDA?
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets (K162304) received a 510(k) decision of Substantially Equivalent on December 6, 2016, 111 days after the submission was received.
What is the product code of K162304?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.