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# Outset Medical Illegally Marketing Tablo System: FDA
- URL: https://www.fdaweb.com/outset-medical-illegally-marketing-tablo-system-fda/
- Published: 2023-07-18T12:00:00.000Z
- Updated: 2026-09-14T18:44:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154894

A 1/17-2/10 FDA inspection at Outset Medical in San Jose, CA, found that the company manufactures the Tablo Hemodialysis System and TabloCart with Prefiltration. A 7/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/outset-medical-inc-656485-07052023?ref=fdaweb.com) says Outset does not have approved applications for PMA approval for either of the devices, rendering them both adulterated. The letter says the firm has a 510(k) clearance for the hemodialysis system but that the indications for use have been significantly changed without obtaining new clearance.

FDA says the firm’s 3/3 response does not address the inspection observations.

Outset was told to act promptly to correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent them from recurring, with documentation of the corrections and a schedule for completing them.