DEKA Infusion System, DEKA Administration Set
FDA 510(k) K232316 · Deka Research and Development
510(k) numberK232316
Submission
- Device name
- DEKA Infusion System, DEKA Administration Set
- Applicant
- Deka Research and Development
Manchester, NH, US - Received
- August 3, 2023
- Decision date
- March 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code LDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | Deka Research and Development Corporation | 10/07/2024SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | DEKA Research & Development | 10/03/2016SE |
| K963136 | Pacer Model 100 Infusion ControllerLDR · Traditional | Health Watch, Inc. | 10/10/1997SE |
| K971865 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K971826 | Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
| K934543 | Universal Controller, Model 100LDR · Traditional | Metamed, Inc. | 03/29/1994SE |
| K935236 | Flow Controlling Extension SetLDR · Traditional | Block Medical, Inc. | 02/24/1994SE |
| K905498 | Stat 2 IV PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
| K905497 | Master Flow I.V. PumpetteLDR · Traditional | The Master Medical Corp. | 04/16/1991SE |
| K896907 | 3M IV Flow RegulatorLDR · Traditional | 3M Company | 02/26/1990SE |
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|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) SystemQFG · Special | 06/17/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | 06/03/2026SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | 08/01/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | 01/16/2025SE |
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | 10/07/2024SE |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS)KPO · Traditional | 07/12/2024SE |
| K233557 | HemoCare Hemodialysis SystemKDI · Traditional | 07/12/2024SE |
| K240256 | Remunity SystemQJY · Traditional | 06/12/2024SE |
| K241178 | DEKA ACE Pump SystemQFG · Special | 05/24/2024SE |
| K234055 | DEKA LoopQJI · Traditional | 03/13/2024SE |
Questions and answers
When was DEKA Infusion System, DEKA Administration Set cleared by the FDA?
DEKA Infusion System, DEKA Administration Set (K232316) received a 510(k) decision of Substantially Equivalent on March 1, 2024, 211 days after the submission was received.
What is the product code of K232316?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.