Amicon Equaline Fluid Balance System
FDA 510(k) K875121 · Amicon, Inc.
510(k) numberK875121
Submission
- Device name
- Amicon Equaline Fluid Balance System
- Applicant
- Amicon, Inc.
Danvers, MA, US - Received
- December 15, 1987
- Decision date
- February 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPF – System, Dialysate Delivery, Semi-Automatic, Peritoneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061515 | RenalsoftKPF · Traditional | Baxter Healthcare Corp | 09/11/2006SE |
| K990953 | Renal LinkKPF · Traditional | Baxter Healthcare Corp | 06/18/1999SE |
| K970989 | CyberrenKPF · Traditional | Cybernius Medical , Ltd. | 07/24/1997SE |
| K955762 | Packpd Peritoneal Dialysis Urea Kinetic Modeling Software ProgramKPF · Traditional | Fresenius USA, Inc. | 07/31/1996SE |
| K913515 | Total Containment DeviceKPF · Traditional | Denco | 05/26/1994SE |
| K874020 | Ultracare(Tm) Automated Patient Assist DeviceKPF · Traditional | Abbott Laboratories | 01/29/1988SE |
| K821328 | C.A.P.D. Automatic Heater #Pdc 2000 HCPKPF · Traditional | Medionics International , Ltd. | 07/28/1982SE |
| K802831 | Gambro Peritoneal Dialysis MonitorKPF · Traditional | Gambro, Inc. | 12/18/1980SE |
| K800496 | Cycler W/5 or 10 Hr. Fill/Dwell TimerKPF · Traditional | American Medical Products, Inc. | 07/21/1980SE |
| K791676 | Peritoneal Dialysis Cycler Model PDC1000KPF · Traditional | J.M. Sounds Electronics Co. | 12/06/1979SE |
More from J.M. Sounds Electronics Co.
| 510(k) | Device | Decision |
|---|---|---|
| K930168 | Centricon -50 ConcentratorJJH · Traditional | 08/05/1993SE |
| K902837 | Amicon Diafilter 30 HemoconcentratorKDI · Traditional | 11/01/1990SE |
| K901286 | Amicon Hemoconcentrator SetKDI · Traditional | 05/18/1990SE |
| K900280 | Centriprep 100JJP · Traditional | 02/16/1990SE |
| K895405 | Amicon Minifilter Plus HemofilterKDI · Traditional | 01/11/1990SE |
| K893733 | Centricon ConcentratorJJH · Traditional | 07/20/1989SE |
| K892645 | Amicon Vitafiber Flo-Path Biorect/Vls Cell Cult SyKJF · Traditional | 06/13/1989SE |
| K870690 | Centriprep ConcentratorJJH · Traditional | 03/19/1987SE |
| K863823 | Amicon Diafilter HemofilterKDI · Traditional | 11/06/1986SE |
| K853510 | Minifilter HemofilterKDI · Traditional | 09/12/1985SE |
Questions and answers
When was Amicon Equaline Fluid Balance System cleared by the FDA?
Amicon Equaline Fluid Balance System (K875121) received a 510(k) decision of Substantially Equivalent on February 19, 1988, 66 days after the submission was received.
What is the product code of K875121?
The FDA product code is KPF – System, Dialysate Delivery, Semi-Automatic, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5630.