Bioteque 3 in 1 Hemodialysis Blood Tubing Pack
FDA 510(k) K013634 · Bioteque Corp.
510(k) numberK013634
Submission
- Device name
- Bioteque 3 in 1 Hemodialysis Blood Tubing Pack
- Applicant
- Bioteque Corp.
Flagstaff, AZ, US - Received
- November 5, 2001
- Decision date
- July 9, 2002
- Decision
- Unknown (SESK)
- 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 |
| 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 |
|---|---|---|
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | 12/22/2025SE |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-seriesFGE · Traditional | 04/13/2022SE |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type)FGE · Traditional | 10/09/2020SE |
| K150932 | Sheath IntroducerDRE · Traditional | 07/22/2016SE |
| K102633 | Bioteq Angiographic CatheterDQO · Traditional | 09/09/2011SE |
| K033862 | Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String LockFGE · Traditional | 02/14/2005SE |
| K033210 | Bioteq Double Pigtail Ureteral Stent SetFAD · Traditional | 12/30/2004SE |
| K032292 | Bioteque A.V. Fistula Needle Set with Safety FlexFOZ · Traditional | 03/22/2004SE |
| K012526 | Bioteque Scalp Vein SetFPA · Traditional | 09/14/2001SE |
| K002449 | Bioteq I.V. (Intravenous) SetFPA · Traditional | 12/22/2000SE |
Questions and answers
When was Bioteque 3 in 1 Hemodialysis Blood Tubing Pack cleared by the FDA?
Bioteque 3 in 1 Hemodialysis Blood Tubing Pack (K013634) received a 510(k) decision of Unknown on July 9, 2002, 246 days after the submission was received.
What is the product code of K013634?
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.