HPR Home Patient Renatron
FDA 510(k) K833181 · Renal Systems, Inc.
510(k) numberK833181
Submission
- Device name
- HPR Home Patient Renatron
- Applicant
- Renal Systems, Inc.
Mchenry, IL, US - Received
- September 19, 1983
- Decision date
- October 27, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIF – Dialyzer Reprocessing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091360 | Clearflux Dialyzer Reprocessing SystemLIF · Traditional | Novaflux Technologies | 11/03/2010SE |
| K043126 | Assist Header CleanerLIF · Traditional | Alcavis International, Inc. | 02/03/2005SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | Hach Company | 11/15/2004SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 04/27/2004SE |
| K024076 | Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional | Hdc Maquinolas, LLC | 09/26/2003SE |
| K013713 | Arm Automatic Reprocessing MachineLIF · Traditional | Alcavis International Incorporated | 07/15/2002SE |
| K992016 | Amukin DLIF · Traditional | Amuchina Intl., Inc. | 01/10/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 08/30/1999SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | Reprocessing Products Corp | 02/10/1999SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
More from Environmental Test Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | 01/05/1998SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | 06/09/1987SE |
| K854011 | Renalfo Hemofilter CavhdKDI · Traditional | 11/05/1985SE |
| K844790 | Renaflo HemoconcentratorKDI · Traditional | 05/23/1985SE |
| K844108 | Renal Systems Peritoneal Access SystemFKX · Traditional | 01/07/1985SE |
| K843963 | Dialysate Concentrate for Hemodialysis-Liquid/PowdFKQ · Traditional | 01/07/1985SE |
| K842258 | RenatronLIF · Traditional | 07/06/1984SE |
| K841543 | Concentrate Conductivity MeterFKQ · Traditional | 05/22/1984SE |
| K840182 | Renapak Concentrate Mixing Sys.FKQ · Traditional | 05/02/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | 02/21/1984SE |
Questions and answers
When was HPR Home Patient Renatron cleared by the FDA?
HPR Home Patient Renatron (K833181) received a 510(k) decision of Substantially Equivalent on October 27, 1983, 38 days after the submission was received.
What is the product code of K833181?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.