Cycler W/5 or 10 Hr. Fill/Dwell Timer
FDA 510(k) K800496 · American Medical Products, Inc.
510(k) numberK800496
Submission
- Device name
- Cycler W/5 or 10 Hr. Fill/Dwell Timer
- Applicant
- American Medical Products, Inc.
Mchenry, IL, US - Received
- March 4, 1980
- Decision date
- July 21, 1980
- 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 |
| 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 |
| 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 |
|---|---|---|
| K922290 | Single-Step Pregnancy, HCG TestJHI · Traditional | 07/09/1992SE |
| K862221 | E-Z CleanGEI · Traditional | 09/12/1986SE |
| K861251 | Amp Closed Urinary Drainage Bag, 1011 & 1011NKNX · Traditional | 04/17/1986SE |
| K830881 | Ampercide Disinfectant Accessory to -FKX · Traditional | 06/02/1983SE |
| K823827 | Amp 80/2 Outflow Monitor ModificationFKX · Traditional | 03/17/1983SE |
| K822551 | Amp Capd Unispike Aministration SetFKK · Traditional | 10/13/1982SE |
| K822550 | Safe Lock Titanium Adapter SetFKX · Traditional | 10/13/1982SE |
| K822549 | CCPD Cycler Set W/5 Pronged Safe LockFKX · Traditional | 10/13/1982SE |
| K822548 | Safe Lock Catheter S-3FKX · Traditional | 10/13/1982SE |
| K822546 | Safe Lock Sealing CapsFKX · Traditional | 10/13/1982SE |
Questions and answers
When was Cycler W/5 or 10 Hr. Fill/Dwell Timer cleared by the FDA?
Cycler W/5 or 10 Hr. Fill/Dwell Timer (K800496) received a 510(k) decision of Substantially Equivalent on July 21, 1980, 139 days after the submission was received.
What is the product code of K800496?
The FDA product code is KPF – System, Dialysate Delivery, Semi-Automatic, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5630.