Tablo Cartridge
FDA 510(k) K210782 · Outset Medical, Inc.
510(k) numberK210782
Submission
- Device name
- Tablo Cartridge
- Applicant
- Outset Medical, Inc.
San Jose, CA, US - Received
- March 16, 2021
- Decision date
- November 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 05/15/2026SE |
| K251341 | VITAL Tubing Sets for HemodialysisFJK · Traditional | Vital Healthcare Sdn. Bhd. | 01/16/2026SE |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)FJK · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 10/02/2025SE |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 )FJK · Special | Diality, Inc. | 12/20/2024SE |
| K213992 | CombiSet Hemodialysis Blood Tubing SetFJK · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/31/2023SE |
| K202796 | SANSIN Tubing Sets for HemodialysisFJK · Traditional | Jiangxi Sanxin Medtec Co., Ltd. | 09/06/2021SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 03/10/2021SE |
| K171952 | Dimesol Tubing Sets for HemodialysisFJK · Traditional | Dimesol, Inc. | 03/30/2018SE |
| K161582 | DORA Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/16/2017SE |
| K150304 | Oxyless Blood Tubing SetFJK · Abbreviated | Oxyless, Ltd. | 02/24/2016SE |
More from Oxyless, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | 01/26/2026SE |
| K232776 | Tablo® Hemodialysis System; TabloCart with Prefiltration DrawerKDI · Traditional | 05/03/2024SE |
| K233335 | Tablo® Hemodialysis SystemKDI · Traditional | 12/05/2023SE |
| K223248 | Tablo® Hemodialysis SystemKDI · Traditional | 06/21/2023SE |
| K211370 | Tablo Hemodialysis SystemKDI · Traditional | 07/29/2022SE |
| 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 Cartridge cleared by the FDA?
Tablo Cartridge (K210782) received a 510(k) decision of Substantially Equivalent on November 26, 2021, 255 days after the submission was received.
What is the product code of K210782?
The FDA product code is FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, a Class II (moderate risk) device regulated under 21 CFR 876.5820.