# Fresenius Kabi USA,Llc

- Location (FDA's records): Lake Zurich, IL
- FDA decisions: 2 (2016–2018): 2 510(k) clearances
- Product codes: LKN (1), GKT (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terumobct, Inc.: 1 (https://510kreport.com/company/terumobct)
- Fenwal, Inc.: 1 (https://510kreport.com/company/fenwal)

## Firms that cite its devices most
- Fresenius Kabi AG: 1 (https://510kreport.com/company/fresenius-kabi)

## Its most-cited devices
- K180615: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (2018), cited by 1

## Recent decisions
- K180615: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (Dec 4, 2018)
- K162462: AMICUS Separator System, AMICUS Separator System; Refurbished (Nov 23, 2016)

Source page: https://510kreport.com/company/fresenius-kabi-usa