# K251019: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corporation
- Decided: Dec 22, 2025 after 264 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: 4 generations back to K003753 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210419: BIOTEQ Drainage Catheter BT-PDS-series, Bioteque Corporation (2022) Summary page 5.
- K200103: BIOTEQ Drainage Catheter Set (One Step Type), Bioteque Corporation (2020) Summary page 6.

## Indications for use
The catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

Source page: https://510kreport.com/device/K251019
Methodology: https://510kreport.com/methodology