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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990643 | PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL | Althin Medical AB an Affiliate of Baxter Intl | 1999-12-07 | 284 | 0 |
| K970679 | ALTRA FLUX 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 | 514 | 0 |
| K970681 | ALTRA NOVA 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 | 514 | 0 |
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SY | Althin Medical AB an Affiliate of Baxter Intl | 1997-06-02 | 117 | 5 |
| K964922 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOU | Althin Medical AB an Affiliate of Baxter Intl | 1997-05-21 | 163 | 0 |
| K955384 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE | Althin Medical AB an Affiliate of Baxter Intl | 1997-01-10 | 415 | 0 |
| K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | Althin Medical AB an Affiliate of Baxter Intl | 1996-12-27 | 193 | 0 |
| K954987 | ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM | Althin Medical AB an Affiliate of Baxter Intl | 1996-08-08 | 282 | 1 |
| K952978 | ALTRA FLUX 110 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-10-05 | 100 | 0 |
| K952982 | ALTREX 110 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-10-05 | 100 | 0 |
| K952983 | ALTR NOVA 110 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-10-05 | 99 | 0 |
| K945621 | ALTRA NOVA(TM) 170 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-30 | 196 | 0 |
| K945625 | ALTRA NOVA(TM) 140 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-30 | 196 | 0 |
| K945622 | MCA(TM) 180 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-25 | 191 | 0 |
| K945542 | ALTRA FLUX(TM) 170 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-23 | 190 | 0 |
| K945620 | ALTRA FLUX(TM) 140 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | 184 | 0 |
| K945623 | MCA(TM) 130 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | 184 | 0 |
| K945624 | MCA(TM) 160 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | 184 | 0 |
| K945631 | 155 SCE(TM) HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | 183 | 0 |
| K945595 | ALTREX(R) 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-03-08 | 114 | 0 |
| K945596 | ALTRES(R) 140 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-03-08 | 114 | 0 |
| K945597 | ALTRES(R) 170 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-03-08 | 114 | 0 |
| K926372 | MCA 200 HEMPDIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-02-13 | 783 | 0 |
| K926373 | ALTRA FLUX 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-02-13 | 783 | 0 |
| K926379 | ALTRA NOVA 200 HEMODAILYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-02-13 | 783 | 0 |
| K913526 | SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS | Althin Medical AB an Affiliate of Baxter Intl | 1991-11-01 | 85 | 0 |
| K913950 | DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY | Althin Medical AB an Affiliate of Baxter Intl | 1991-11-01 | 58 | 0 |
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