Renal Link
FDA 510(k) K990953 · Baxter Healthcare Corp
510(k) numberK990953
Submission
- Device name
- Renal Link
- Applicant
- Baxter Healthcare Corp
Mcgaw Park, IL, US - Received
- March 22, 1999
- Decision date
- June 18, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 |
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Questions and answers
When was Renal Link cleared by the FDA?
Renal Link (K990953) received a 510(k) decision of Substantially Equivalent on June 18, 1999, 88 days after the submission was received.
What is the product code of K990953?
The FDA product code is KPF – System, Dialysate Delivery, Semi-Automatic, Peritoneal, a Class II (moderate risk) device regulated under 21 CFR 876.5630.