Tablo® Hemodialysis System— 510(k) K233335
Substantially EquivalentOutset Medical, Inc.
FDA 510(k) clearance K233335 for Tablo® Hemodialysis System, Substantially Equivalent on 2023-12-05. Applicant: Outset Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Outset Medical, Inc.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code KDI
view allMore clearances from Outset Medical, Inc.
view allAdverse 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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K233335
K-number listed on FDA's recall record- Z-0019-2025 — Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
- Z-2150-2024 — TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
- Z-1485-2024 — Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233335.
Data sourced from openFDA. This site is unofficial and independent of the FDA.