Therapeutic Exchange Blood TUBING-TP-101
FDA 510(k) K831424 · Extracorporeal Medical Specialities, Inc.
510(k) numberK831424
Submission
- Device name
- Therapeutic Exchange Blood TUBING-TP-101
- Applicant
- Extracorporeal Medical Specialities, Inc.
Mchenry, IL, US - Received
- May 3, 1983
- Decision date
- October 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K210782 | Tablo CartridgeFJK · Traditional | Outset Medical, Inc. | 11/26/2021SE |
| 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 |
More from Bain Medical Equipment (Guangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K843955 | Extracorporeal Maxima Hollow Fiber OxygenatorDTZ · Traditional | 11/29/1984SE |
| K840532 | Hemoperfusion System TP-400FLD · Traditional | 05/30/1984SE |
| K840262 | Hancock Pericardial PatchDXZ · Traditional | 05/30/1984SE |
| K840146 | Exp* 700 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K840057 | Exp* 500 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K832547 | Ultrafiltration ControllerKDI · Traditional | 01/03/1984SE |
| K831423 | Therapeutic Exchange SystemLQQ · Traditional | 01/03/1984SE |
| K833477 | Intersept 40 Micron FilterDTM · Traditional | 12/27/1983SE |
| K833476 | Intersept 40 Micron Filter W/TubingDTM · Traditional | 12/27/1983SE |
| K832053 | Single Patient Sys. II Model DM-450KOC · Traditional | 09/29/1983SE |
Questions and answers
When was Therapeutic Exchange Blood TUBING-TP-101 cleared by the FDA?
Therapeutic Exchange Blood TUBING-TP-101 (K831424) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 164 days after the submission was received.
What is the product code of K831424?
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.