Outset Medical, Inc.

Warning LetterClosed

Ms. Leslie L. Trigg CEO & Chair Outset Medical, Inc. 3052 Orchard Drive San Jose , CA 95134-2011 United StatesFEI 3010355846Issued Jul 5, 2023Center for Devices and Radiological Health

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Violations3

Issue DateJul 5, 2023

Product TypeMedical Devices

StatusClosed

Closeout LetterFeb 19, 2025

Letter Details

Firm: Outset Medical, Inc.
Location: Ms. Leslie L. Trigg CEO & Chair Outset Medical, Inc. 3052 Orchard Drive San Jose , CA 95134-2011 United States
FEI Number: 3010355846
Country: United States
Issue Date: July 05, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: February 19, 2025

Summary

Outset Medical, Inc. was cited for manufacturing the TabloCart with Prefiltration, a hemodialysis device component, without required premarket approval (PMA) or investigational device exemption (IDE), rendering it adulterated under federal law. The company also failed to submit a premarket notification (510(k)) to notify FDA of the device's intent for commercial distribution, violating device misbranding requirements. These violations were identified during an FDA inspection conducted from January 17 through February 10, 2023, at the company's San Jose, California facility.

Outset Medical, Inc. FDA Warning Letter, July 5, 2023