# K210419: BIOTEQ Drainage Catheter BT-PDS-series

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corporation
- Decided: Apr 13, 2022 after 426 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003753 (2001). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200103: BIOTEQ Drainage Catheter Set (One Step Type), Bioteque Corporation (2020) Summary page 4.

## Most influential descendants
- K254179: Drainage Catheter (2026), 0 descendants of its own
- K251019: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (2025), 0 descendants of its own

## Indications for use
The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids.

Source page: https://510kreport.com/device/K210419
Methodology: https://510kreport.com/methodology