# Fenwal, Inc.

- Location (FDA's records): Lake Zurich, IL
- FDA decisions: 4 (1983–2014): 3 510(k) clearances and 1 original PMA approval
- Product codes: LKN (2), LMN (1), BRZ (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cobe Laboratories, Inc.: 1 (https://510kreport.com/company/cobe-laboratories)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Travenol Laboratories, S.A.: 1 (https://510kreport.com/company/travenol-laboratories)

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

## Its most-cited devices
- K111702: Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe (2012), cited by 1
- K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector (2008), cited by 1
- K141019: Amicus Separator System/ Amicus Seperator System;Refurbished (2014), cited by 1

## Recent decisions
- K141019: Amicus Separator System/ Amicus Seperator System;Refurbished (Jun 10, 2014)
- K111702: Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe (Mar 22, 2012)
- K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector (Mar 3, 2008)
- P820032: Plasma Separation System (Oct 7, 1983)

Source page: https://510kreport.com/company/fenwal