C.A.P.D. Automatic Heater #Pdc 2000 HCP
FDA 510(k) K821328 · Medionics International , Ltd.
510(k) numberK821328
Submission
- Device name
- C.A.P.D. Automatic Heater #Pdc 2000 HCP
- Applicant
- Medionics International , Ltd.
Mchenry, IL, US - Received
- May 4, 1982
- Decision date
- July 28, 1982
- 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 |
| K875121 | Amicon Equaline Fluid Balance SystemKPF · Traditional | Amicon, Inc. | 02/19/1988SE |
| K874020 | Ultracare(Tm) Automated Patient Assist DeviceKPF · Traditional | Abbott Laboratories | 01/29/1988SE |
| 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 |
|---|---|---|
| K130441 | Faller StyletFJS · Traditional | 04/19/2013SE |
| K993149 | Peritoneal Dialysis Catheters and AdaptersFJS · Traditional | 04/28/2000SE |
| K994218 | Easy Care and Tubing SetsFKX · Special | 02/10/2000SE |
| K945567 | QC CapKDJ · Traditional | 02/07/1995SE |
| K910173 | Selectra and Tubing SetsFKX · Traditional | 01/13/1992SE |
| K883393 | Capd Disposable Y System - Dy SetKDJ · Traditional | 11/03/1988SE |
| K842305 | C.A.P.D. Automatic Heater PDH 200FKX · Traditional | 06/25/1984SE |
| K832141 | Microstar VC1 Volumetric CyclerFKX · Traditional | 10/14/1983SE |
| K831766 | Microstar VciFKX · Traditional | 10/14/1983SE |
Questions and answers
When was C.A.P.D. Automatic Heater #Pdc 2000 HCP cleared by the FDA?
C.A.P.D. Automatic Heater #Pdc 2000 HCP (K821328) received a 510(k) decision of Substantially Equivalent on July 28, 1982, 85 days after the submission was received.
What is the product code of K821328?
The FDA product code is KPF – System, Dialysate Delivery, Semi-Automatic, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5630.