LDR · Controller, Infusion, Intravascular, Electronic
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | LDR |
|---|---|
| Device Name | Controller, Infusion, Intravascular, Electronic |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 60)
Showing 20 most recent of 60 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | Oct 7, 2024 | SESE |
| K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | Mar 1, 2024 | SESE |
| K153760 | Volumetric Infusion Controller | DEKA Research & Development | Oct 3, 2016 | SESE |
| K963136 | PACER MODEL 100 INFUSION CONTROLLER | Health Watch, Inc. | Oct 10, 1997 | SESE |
| K971865 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | Alexander Mfg. Co. | Jul 3, 1997 | SESE |
| K971826 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 | Alexander Mfg. Co. | Jul 3, 1997 | SESE |
| K934543 | UNIVERSAL CONTROLLER, MODEL 100 | Metamed, Inc. | Mar 29, 1994 | SESE |
| K935236 | FLOW CONTROLLING EXTENSION SET | Block Medical, Inc. | Feb 24, 1994 | SESE |
| K905498 | STAT 2 IV PUMPETTE | The Master Medical Corp. | Apr 16, 1991 | SESE |
| K905497 | MASTER FLOW I.V. PUMPETTE | The Master Medical Corp. | Apr 16, 1991 | SESE |
| K896907 | 3M IV FLOW REGULATOR | 3M Company | Feb 26, 1990 | SESE |
| K894111 | VARI-SET | Sonex Medical | Sep 28, 1989 | SESE |
| K894487 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ | Y | Sep 27, 1989 | SESE |
| K893487 | LIFECARE 75 CONTROLLER | Abbott Laboratories | Jul 28, 1989 | SESE |
| K884307 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 | Y | Nov 1, 1988 | SESE |
| K882167 | IVY COMMANDER, MODEL 600 | Ivy Medical, Inc. | Sep 23, 1988 | SESE |
| K880006 | STA-SET I.V. FLOW REGULATOR | Controlled Flow , Ltd. | Mar 24, 1988 | SESE |
| K874916 | TECHNICON CHEM 1(TM) SYSTEM | Technicon Instruments Corp. | Mar 3, 1988 | SESE |
| K874481 | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 | Y | Mar 3, 1988 | SESE |
| K874491 | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ | Y | Feb 25, 1988 | SESE |
Top Applicants
- Y — 8 clearances
- Travenol Laboratories, S.A. — 4 clearances
- Abbott Laboratories — 3 clearances
- Ivy Medical, Inc. — 3 clearances
- Alexander Mfg. Co. — 2 clearances
