Tablo Hemodialysis System, Tablo Cartridge— 510(k) K190793
Substantially EquivalentOutset Medical, Inc.
FDA 510(k) clearance K190793 for Tablo Hemodialysis System, Tablo Cartridge, Substantially Equivalent on 2019-12-12. 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 K190793
K-number listed on FDA's recall record- Z-1351-2023 — Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
- Z-0813-2022 — Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190793.
Data sourced from openFDA. This site is unofficial and independent of the FDA.