# K222385: Bifurcated Needle

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Dec 6, 2022 after 120 days
- Product code: SCL (Allergen And Vaccine Delivery Needles)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K012515 (2001). 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)
- K020523: BD Bifurcated Needle, Models 301754, 301755, 301756, 301757, Bd (2002) Summary page 4.

## Indications for use
The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

Source page: https://510kreport.com/device/K222385
Methodology: https://510kreport.com/methodology