# K013634: Bioteque 3 in 1 Hemodialysis Blood Tubing Pack

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Jul 9, 2002 after 246 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972206 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972206: Nipro Blood Tubing Set with Transducer and Solution Set for Hemodialysis, Nipro Medical Corp. (1997) Summary page 1.
- K001465: Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set, Nipro Medical Corp. (2000) Summary page 1.

## Indications for use
The BIOTEQ* 3 in 1 Hemodialysis Blood Tubing Packs ( BT- 102DA BT- 102DB BT- 102DC BT- 102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterialhenous bloodline set, and any combination of two or three component of the following items: * An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) , * AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , andor * A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).

Source page: https://510kreport.com/device/K013634
Methodology: https://510kreport.com/methodology