Requiring modifications to the following hemodialysis machines manufactured by Fresenius USA, Inc., in order to provide safer hemodialysis treatments for patients and consumers 2008K2 Hemodialysis Machines, cleared under 510(k) no. K153449; the 2008T Hemodialysis Machines, first cleared under 510(k) no. K173972. K080964; and the 2008T BlueStar Hemodialysis Machines, cleared under 510(k) no. K17397 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2023-P-0219

Requiring modifications to the following hemodialysis machines manufactured by Fresenius USA, Inc., in order to provide safer hemodialysis treatments for patients and consumers 2008K2 Hemodialysis Machines, cleared under 510(k) no. K153449; the 2008T Hemodialysis Machines, first cleared under 510(k) no. K173972. K080964; and the 2008T BlueStar Hemodialysis Machines, cleared under 510(k) no. K17397

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensJan 23, 2023

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Jul 20, 2026	--

Keywords

Citizen Petition

CDRH

United Healthcare Workers West

Requiring modifications to the following

hemodialysis machines manufactured by Fresenius

USA, Inc., in order to provide safer hemodialy

treatments for patients and consumers 2008K2

2008K2 Hemodialysis Machines, cleared under

Data from Regulations.gov