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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Althin Medical AB an Affiliate of Baxter Intl · Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

184 daysmedian FDA review time
783 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990643PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL Althin Medical AB an Affiliate of Baxter Intl1999-12-072840
K970679ALTRA FLUX 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1998-07-235140
K970681ALTRA NOVA 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1998-07-235140
K970446DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYAlthin Medical AB an Affiliate of Baxter Intl1997-06-021175
K964922DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUAlthin Medical AB an Affiliate of Baxter Intl1997-05-211630
K955384DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLEAlthin Medical AB an Affiliate of Baxter Intl1997-01-104150
K962309ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERSAlthin Medical AB an Affiliate of Baxter Intl1996-12-271930
K954987ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEMAlthin Medical AB an Affiliate of Baxter Intl1996-08-082821
K952978ALTRA FLUX 110 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-10-051000
K952982ALTREX 110 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-10-051000
K952983ALTR NOVA 110 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-10-05990
K945621ALTRA NOVA(TM) 170 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-301960
K945625ALTRA NOVA(TM) 140 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-301960
K945622MCA(TM) 180 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-251910
K945542ALTRA FLUX(TM) 170 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-231900
K945620ALTRA FLUX(TM) 140 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-181840
K945623MCA(TM) 130 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-181840
K945624MCA(TM) 160 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-181840
K945631155 SCE(TM) HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-05-181830
K945595ALTREX(R) 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-03-081140
K945596ALTRES(R) 140 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-03-081140
K945597ALTRES(R) 170 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-03-081140
K926372MCA 200 HEMPDIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-02-137830
K926373ALTRA FLUX 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl1995-02-137830
K926379ALTRA NOVA 200 HEMODAILYZERAlthin Medical AB an Affiliate of Baxter Intl1995-02-137830
K913526SERAFLO ARTERIAL AND VENOUS BLOODLINE SETSAlthin Medical AB an Affiliate of Baxter Intl1991-11-01850
K913950DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEYAlthin Medical AB an Affiliate of Baxter Intl1991-11-01580

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda