Outset Medical, Inc. · Class II · Cleared Jan 26, 2026
| K-number | K253412 |
| Device name | Tablo Hemodialysis System (PN-0008000, PN-0006000U) |
| Applicant | Outset Medical, Inc. |
| Product code | KDI |
| Device class | Class II |
| Decision date | Jan 26, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.5860 |
The Tablo® Hemodialysis System is a self-contained hemodialysis device for acute and chronic renal failure treatment with or without ultrafiltration in clinical or home settings. It consists of a console with integrated dialysis delivery and water purification, plus a cartridge. Treatment types include intermittent hemodialysis, sustained low efficiency dialysis, prolonged intermittent renal replacement therapy, and isolated ultrafiltration, all administered under physician prescription by trained personnel.
The subject device (Console with software version 5.0) incorporates incremental hardware changes to support reliability, serviceability, and cost savings compared to the predicate K233335. Software changes were made to strengthen cybersecurity. The proposed modifications affect components in the fluid pathway assessed as auxiliary components that do not impact water quality or cartridge functionality.
IEC 60601-1-2 (Edition 4.1) for electrical safety and electromagnetic compatibility; ISO 10993-1:2018 for biocompatibility; FDA Guidance for Software Contained in Medical Devices (Enhanced documentation level); FDA Guidance on Cybersecurity in Medical Devices.
View the full FDA submission: accessdata.fda.gov