LDR — Controller, Infusion, Intravascular, Electronic Class II
FDA product code LDR covers "Controller, Infusion, Intravascular, Electronic", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K971865 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | July 3, 1997 |
| K971826 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 | 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 |
| K874916 | technicon instruments | TECHNICON CHEM 1(TM) SYSTEM | March 3, 1988 |
| K874481 | y | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 | March 3, 1988 |
| K874491 | y | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ | February 25, 1988 |