K253412 is an FDA 510(k) clearance for the Tablo Hemodialysis System (PN-0008000, PN-0006000U). This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by Outset Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on January 26, 2026, 118 days after receiving the submission on September 30, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K253412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | January 26, 2026 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDI - Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |