K253412
- 510(k) number
- K253412
- Device name
- Tablo Hemodialysis System (PN-0008000, PN-0006000U)
- Applicant
- Outset Medical, Inc. CA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2026-01-26
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253412.pdf
Official FDA record: K253412
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.