LDR — Controller, Infusion, Intravascular, Electronic Class II
FDA Device Classification
Classification Details
- Product Code
- LDR
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K242693 | deka research and development corporation | DEKA Infusion System, DEKA Administration Set | October 7, 2024 |
| K232316 | deka research and development | DEKA Infusion System, DEKA Administration Set | March 1, 2024 |
| K153760 | deka research and development | Volumetric Infusion Controller | October 3, 2016 |
| K963136 | health watch | PACER MODEL 100 INFUSION CONTROLLER | October 10, 1997 |
| K971826 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 | July 3, 1997 |
| K971865 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | July 3, 1997 |
| K934543 | metamed | UNIVERSAL CONTROLLER, MODEL 100 | March 29, 1994 |
| K935236 | block medical | FLOW CONTROLLING EXTENSION SET | February 24, 1994 |
| K905498 | master medical | STAT 2 IV PUMPETTE | April 16, 1991 |
| K905497 | master medical | MASTER FLOW I.V. PUMPETTE | April 16, 1991 |
| K896907 | 3m | 3M IV FLOW REGULATOR | February 26, 1990 |
| K894111 | sonex medical | VARI-SET | September 28, 1989 |
| K894487 | y | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ | September 27, 1989 |
| K893487 | abbott laboratories | LIFECARE 75 CONTROLLER | July 28, 1989 |
| K884307 | y | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 | November 1, 1988 |
| K882167 | ivy medical | IVY COMMANDER, MODEL 600 | September 23, 1988 |
| K880006 | controlled flow | STA-SET I.V. FLOW REGULATOR | March 24, 1988 |
| K874481 | y | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 | March 3, 1988 |
| K874916 | technicon instruments | TECHNICON CHEM 1(TM) SYSTEM | March 3, 1988 |
| K874491 | y | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ | February 25, 1988 |