Tablo Hemodialysis System, Tablo Cartridge— 510(k) K190793

Substantially Equivalent

Outset Medical, Inc.

FDA 510(k) clearance K190793 for Tablo Hemodialysis System, Tablo Cartridge, Substantially Equivalent on 2019-12-12. Applicant: Outset Medical, Inc..

Clearance details

Applicant: Outset Medical, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-28
Decision date: 2019-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.