# K992930: Bioteque Hemodialysis Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Feb 9, 2000 after 162 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 K853851 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853851: Fresenius Disposable Blood Lines, Seratronics, Inc. (1985) Summary page 1.

## Indications for use
The BIOTEQ Hemodialysis Blood Tubing Set (Models BT-102A, BT-102B, and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.

Source page: https://510kreport.com/device/K992930
Methodology: https://510kreport.com/methodology