Company
Baxter Healthcare Renal Div
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
46recalls (0 in 12 months)
45recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 16 |
| FKX | System, Peritoneal, Automatic Delivery | 15 |
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | 7 |
| FKP | System, Dialysate Delivery, Single Patient | 3 |
| FII | System, Dialysate Delivery, Sealed | 2 |
| JPI | Device, Hematocrit Measuring | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2012 | Baxter Healthcare Renal Div Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter He Terminated |
FKX | K923065 |
| Nov 7, 2011 | Baxter Healthcare Renal Div Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P.
Hemodialysis and Continuous Renal Rep Terminated |
KDI | K970446 |
| Jul 6, 2011 | Baxter Healthcare Renal Div Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560 Terminated |
FKX | None listed |
| May 3, 2011 | Baxter Healthcare Renal Div APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Terminated |
FKX | K053512 |
| Apr 12, 2010 | Baxter Healthcare Renal Div Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Terminated |
FKP | K883111 |
| Mar 1, 2010 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R.
The HomeChoice dialysis system is a personal cycler automated perito Terminated |
FKX | K053512 |
| Mar 1, 2010 | Baxter Healthcare Renal Div Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D and 5C447DR.
The HomeChoice dialysis system is a personal cycle Terminated |
FKX | K053512 |
| Nov 12, 2009 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
The Hemodialysis and Continuous Renal Terminated |
KDI | K013562 K954987 |
| Mar 7, 2008 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U Terminated |
FKX | K012988 |
| Mar 7, 2008 | Baxter Healthcare Renal Div Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U Terminated |
FKX | K923065 |
| Jan 26, 2008 | Baxter Healthcare Renal Div Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085. Terminated |
KPF | K061515 |
| Jan 26, 2008 | Baxter Healthcare Renal Div Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K061515 |
| Nov 14, 2006 | Baxter Healthcare Renal Div Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Jul 25, 2006 | Baxter Healthcare Renal Div Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; Baxter Healthcare C Terminated |
KDI | K030099 K103562 +2 |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, Renal Software Suite v.3.1 - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, RenalSoft v.1.1 - PD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illin Terminated |
KPF | K990953 |
| Apr 18, 2006 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FKP | K910215 |
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R Terminated |
KOC | K911315 |
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM11A Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3051, 5M3051R Terminated |
KDI | K970591 |
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a BM11A Blood Monitor Pump (5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module (5M3052/5M3052R), with Terminated |
KDI | K974652 |
| Jan 6, 2006 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
KDI | K013562 K030099 +1 |
| Dec 14, 2005 | Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Nov 16, 2005 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Ger Terminated |
KDI | K021615 |
| Nov 16, 2005 | Baxter Healthcare Renal Div Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A. Terminated |
FKX | K012988 |
| Aug 24, 2005 | Baxter Healthcare Renal Div Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
KDI | K030099 |
| Aug 24, 2005 | Baxter Healthcare Renal Div Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3TD, SYS1000L2C2; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
JPI | K970446 |
| Aug 18, 2005 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Ger Terminated |
KDI | K021615 |
| Jul 19, 2005 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5 Terminated |
FKX | K012988 |
| Jul 19, 2005 | Baxter Healthcare Renal Div HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, Terminated |
FKX | K923065 |
| Jun 30, 2005 | Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Jan 15, 2005 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R Terminated |
FKX | K012988 |
| Dec 24, 2004 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FII | K030099 K872364 +2 |
| Dec 9, 2004 | Baxter Healthcare Renal Div Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and doubl Terminated |
KDJ | K883239 |
| Dec 8, 2004 | Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Dec 2, 2004 | Baxter Healthcare Renal Div Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Cor Terminated |
FKP | K910215 |
| Nov 11, 2004 | Baxter Healthcare Renal Div HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, T5C8300 Terminated |
FKX | K012988 |
| Nov 11, 2004 | Baxter Healthcare Renal Div HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, T5C4441, T5C4441 Terminated |
FKX | K012988 |
| Aug 11, 2004 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
KDI | K021615 |
| Jul 20, 2004 | Baxter Healthcare Renal Div HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, Terminated |
FKX | K012988 |
| Jul 20, 2004 | Baxter Healthcare Renal Div HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, Terminated |
FKX | K923065 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K992894 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | K030099 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Cor Terminated |
FII | K970446 |