# K012526: Bioteque Scalp Vein Set

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Sep 14, 2001 after 39 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K771204 (1977). 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)
- K771204: Surflo Winged Infusion Set, Terumo America, Inc. (1977) Summary page 1.
- K862491: Exel Butterfly Scalp Vein Set, Exel Intl. (1986) Summary page 1.

## Indications for use
BIOTEQ® SCALP VEIN SET act as a pathway to administer parenteral fluid/ medication into the patient’s vascular system.

Source page: https://510kreport.com/device/K012526
Methodology: https://510kreport.com/methodology