Volumetric Infusion Controller
FDA 510(k) K153760 · DEKA Research & Development
510(k) numberK153760
Submission
- Device name
- Volumetric Infusion Controller
- Applicant
- DEKA Research & Development
Manchester, NH, US - Received
- December 30, 2015
- Decision date
- October 3, 2016
- 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 |
| K232316 | DEKA Infusion System, DEKA Administration SetLDR · Traditional | Deka Research and Development | 03/01/2024SE |
| 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 |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K250930 | twiist systemQFG · Special | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | 03/11/2025SE |
| K243354 | Remunity SystemQJY · Special | 11/27/2024SE |
| K191313 | Unity Subcutaneous Infusion System for RemodulinQJY · Traditional | 02/21/2020SE |
| K190182 | Unity Subcutaneous Delivery System for RemodulinFRN · Traditional | 05/06/2019SE |
| K172601 | Next Generation iBOTIMK · Traditional | 03/02/2018SE |
| K124018 | Amia Automated PD SystemFKX · Traditional | 06/14/2013SE |
| K093915 | Deka Tac DeviceFIG · Traditional | 08/23/2011SE |
| K103220 | Voyager Peritoneal Dialysis SystemFKX · Traditional | 07/29/2011SE |
| K863204 | Deka Jr.LDR · Traditional | 09/03/1986SE |
Questions and answers
When was Volumetric Infusion Controller cleared by the FDA?
Volumetric Infusion Controller (K153760) received a 510(k) decision of Substantially Equivalent on October 3, 2016, 278 days after the submission was received.
What is the product code of K153760?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.