# Althin Medical AB an Affiliate of Baxter Intl

- Location (FDA's records): Miami Lakes, FL
- FDA decisions: 27 (1991–1999): 27 510(k) clearances
- Product codes: KDI (18), FJI (6), MSF (2), FJK (1)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 19 (6 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cd Medical, Inc.: 4 (https://510kreport.com/company/cd-medical)
- In-Line Diagnostics Corp.: 2 (https://510kreport.com/company/in-line-diagnostics)
- Seratronics, Inc.: 1 (https://510kreport.com/company/seratronics)
- Noninvasive Medical Technology Corp.: 1 (https://510kreport.com/company/noninvasive-medical-technology)

## Firms that cite its devices most
- Althin Medical AB: 6 (https://510kreport.com/company/althin-medical)
- Baxter Healthcare Corp: 4 (https://510kreport.com/company/baxter-healthcare)
- Gambro Renal Care Products: 1 (https://510kreport.com/company/gambro-renal-care-products)
- Research Medical, Inc.: 1 (https://510kreport.com/company/research-medical)
- Quantic Biomedical, Inc.: 1 (https://510kreport.com/company/quantic-biomedical)

## Its most-cited devices
- K954987: Altratouch 1000 Hemodialysis Delivery System (1996), cited by 3
- K945620: Altra Flux (TM) 140 Hemodialyzer (1995), cited by 2
- K955384: Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option (1997), cited by 2
- K926373: Altra Flux 200 Hemodialyzer (1995), cited by 2
- K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System (1997), cited by 2
- K926379: Altra Nova 200 Hemodailyzer (1995), cited by 2

## Recent decisions
- K990643: PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015 (Dec 7, 1999)
- K970681: Altra Nova 200 Hemodialyzer (Jul 23, 1998)
- K970679: Altra Flux 200 Hemodialyzer (Jul 23, 1998)
- K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System (Jun 2, 1997)
- K964922: Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System (May 21, 1997)
- K955384: Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option (Jan 10, 1997)
- K962309: Alternate Encapsulating Resin System for Mca Hemodialyzers (Dec 27, 1996)
- K954987: Altratouch 1000 Hemodialysis Delivery System (Aug 8, 1996)

Source page: https://510kreport.com/company/althin-medical-ab-an-affiliate-of-baxter-intl