Outset Medical’s Tablo Hemodialysis System Cartridge Gets FDA’s 510(k) Clearance

Outset Medical has received 510(k) clearance from the FDA for the disposable cartridges used in the company’s Tablo dialysis system.

The newly cleared sterilization method for the cartridges uses a nonionizing technology that does not involve toxic chemicals, the San Jose, Calif.-based company said.

Outset Medical now plans to source the cartridges through a manufacturing partner in Mexico, which will avoid the expense of air freight from overseas and help mitigate future supply-chain risks, the company said.