Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer
FDA 510(k) K232776 · Outset Medical, Inc.
510(k) numberK232776
Submission
- Device name
- Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer
- Applicant
- Outset Medical, Inc.
San Jose, CA, US - Received
- September 11, 2023
- Decision date
- May 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/15/2026SE |
| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | 01/26/2026SE |
| K233335 | Tablo® Hemodialysis SystemKDI · Traditional | 12/05/2023SE |
| K223248 | Tablo® Hemodialysis SystemKDI · Traditional | 06/21/2023SE |
| K211370 | Tablo Hemodialysis SystemKDI · Traditional | 07/29/2022SE |
| K210782 | Tablo CartridgeFJK · Traditional | 11/26/2021SE |
| K200741 | Tablo Hemodialysis SystemKDI · Traditional | 03/31/2020SE |
| K190793 | Tablo Hemodialysis System, Tablo CartridgeKDI · Traditional | 12/12/2019SE |
| K160881 | Tablo ConsoleKDI · Traditional | 11/15/2016SE |
| K150880 | Tablo Console with Wireless CapabilityKDI · Special | 05/01/2015SE |
Questions and answers
When was Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer cleared by the FDA?
Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer (K232776) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 235 days after the submission was received.
What is the product code of K232776?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.