Tablo Hemodialysis System
Hemodialysis system that combines water purification and on-demand dialysate production in one console, connected to electronic medical records and a data platform, cleared by the FDA for use from hospital to home.
outsetmedical.comAt a glance
- Type
- Device
- Platforms
- Web
- Who it’s for
- Health systems, nurses and patients
- Where it’s available
- United States
- Sources cited
- 4
- In the library since
- 24 September 2026
- Regulatory status
- FDA 510(k) K253412, Tablo Hemodialysis System (PN-0008000, PN-0006000U), cleared 26 January 2026, product code KDI; Outset Medical's earlier FDA records date back to 2015.As recorded from the regulator or the company, with its attribution.
What it does
The company describes Tablo as combining water purification and on-demand dialysate production into a single integrated system, run from tap water, an electrical outlet and a drain, with two-way communication with the cloud and an EMR connection that sends more than 70 treatment data fields.
Independent evidence
Established from a source other than the company.
The FDA cleared the Tablo Hemodialysis System (PN-0008000, PN-0006000U) under 510(k) K253412 on 26 January 2026, product code KDI; Outset Medical's earlier FDA records go back to K150880, the Tablo Console, in 2015. In its SEC filing of 27 January 2026 the company said it expected to begin shipping the next-generation platform in the second quarter of 2026.
What the company says
The company’s own statements, attributed to it and not presented as established fact.
The company describes Tablo as the first hemodialysis system incorporating the FDA's most recent guidance on medical device cybersecurity. Pricing is not published.
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