Tablo Console with Wireless Capability— 510(k) K150880

Name: FDA 510(k) clearance K150880
Creator: U.S. Food and Drug Administration
Published: 2015-05-01

Substantially Equivalent

Outset Medical

FDA 510(k) clearance K150880 for Tablo Console with Wireless Capability, Substantially Equivalent on 2015-05-01. Applicant: Outset Medical. Device class: 2.

Clearance details

Applicant: Outset Medical
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2015-04-01
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U)2026-01-26

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.