Product code LIF— Gastroenterology, Urology
COMPUDIAL/KP-1
- Classification name
- Dialyzer Reprocessing System
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 57
- First cleared
- Most recent
Market context for product code LIF
FDA has cleared devices under product code LIF between 1981 and 2010, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2010
- 2005
- 2004
- 2003
- 2002
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1992
- 1991
- 1990
Top applicants under product code LIF
Recent clearances under product code LIF
- K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM
- K043126 — ASSIST HEADER CLEANER
- K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS
- K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM
- K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM
- K013713 — ARM AUTOMATIC REPROCESSING MACHINE
- K992016 — AMUKIN D
- K991851 — RENACLEAR DIALYZER CLEANING SYSTEM
- K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS
- K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
- K970799 — ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
- K955299 — DPS 4 DIALYZER PREPARATION SYSTEM
- K931336 — DRS 4 DIALYZER REPROCESSING SYSTEM
- K941757 — FORMALIN REUSE CART
- K941867 — RENALIN REUSE CART
- K944539 — DRS 4 ND DIALYZER REPROCESSING SYSTEM
- K944492 — DIALYZER REPROCESSING SYSTEM
- K923529 — DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
- K914123 — SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
- K914580 — DRS-4 DIALYZER REPROCESSING SYSTEM
- K911628 — SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
- K911629 — SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
- K905217 — FORMASURE TEST REAGENT
- K902227 — SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
- K904210 — RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
- K900341 — SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
- K884154 — TRANSLUMINAL ENDARTERECTOMY DEVICE
- K874573 — FRESENIUS PURISTERIL 340 (TM)
- K874034 — ADR-22 AUTOMATIC DIALYZER REPROCESSOR
- K870471 — MODIFIED HR-3000 REUSE ADAPTOR
- K870689 — HR-3000 REUSE ADAPTOR
- K860674 — DRS-4 DIALYZER REPROCESSING SYSTEM
- K860026 — ULTRAMAX III, DIALYZER REPROCESSING DEVICE
- K853817 — COBE REN NEW-D DISPENSING KIT
- K853413 — RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS
- K850799 — RINSE MACHINE KR-4 KIDNEY RINSE-4
- K850127 — FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G
- K843520 — WAREXIN RECOMMENDED ALTERNATIVE DIALYZ
- K841153 — ADAPTOR HR-3000 REUSE
- K842258 — RENATRON
- K833128 — FORMA-FAS-TEST
- K832705 — ULTRAMAX
- K834447 — ECHO MM1000
- K833181 — HPR HOME PATIENT RENATRON
- K832230 — DIALYZER PREPARATION SYS DPS-4
- K831132 — COMPUDIAL/KP-1
- K830722 — SPORIDIDIN-D COLD STERILIZING/SOLUTION
- K830190 — AHR-3000 RE-USE ADAPTOR
- K830575 — RENALIN (TENTATIVE
- K830574 — RENATRON DIALYZER REPROCESSING SYS
- K821863 — DIALYZER REPROCESSING SYSTEM DRS-4
- K821383 — ECHO, MODEL MM-1000
- K820695 — AUTOMATIC DIALYZER REPROCESSOR #ADR-22
- K813107 — COMPUDIAL/KP-1
- K820221 — HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE
- K812230 — MODEL RS 8300
- K802828 — LIXIVITRON
Data sourced from openFDA. This site is unofficial and independent of the FDA.