Outset Medical
Dialysis technology company whose Tablo system combines water purification and dialysate production in one console, connected to electronic records and a data platform, cleared for use from hospital to home.
outsetmedical.comAt a glance
- Headquarters
- San Jose, United States
- Business model
- B2B
- Stage
- Publicly listed
- Products profiled
- 1
- Operating markets
- United States
- Sources cited
- 6
- In the library since
- 24 September 2026
What it does
Outset Medical makes the Tablo Hemodialysis System, which the company describes as combining water purification and on-demand dialysate production in a single integrated system that connects to electronic medical record systems and a proprietary data analytics platform.
Independent evidence
Established from a source other than the company.
The FDA's 510(k) records for the applicant Outset Medical, Inc. of San Jose include K253412, the Tablo Hemodialysis System, decided on 26 January 2026 (product code KDI), and nine earlier Outset Medical records back to K150880, the Tablo Console, in 2015. The company is a public filer with the US SEC (Nasdaq: OM); its business address in its filings is San Jose, California.
What the company says
The company’s own statements, attributed to it and not presented as established fact.
The company says Tablo is trusted by more than 1,000 US healthcare facilities and describes it as the first hemodialysis system incorporating the FDA's most recent guidance on medical device cybersecurity.
Notes on this record
The founding year is not recorded: no source read states it.
Products
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