# K232063: SaliPen

- Pathway: 510(k) (Traditional)
- Applicant: Saliwell, Ltd.
- Decided: Dec 13, 2023 after 155 days
- Product code: QTT (Over The Counter Electrical Salivary Stimulatory System)
- Device class: 2
- Regulation: 21 CFR 872.5560
- 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 P860067 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180838: SaliPen, Saliwell, Ltd. (2018) Summary page 5.
- K220618: SaliPen, Saliwell, Ltd. (2022) Summary page 5.

## Indications for use
SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).

Source page: https://510kreport.com/device/K232063
Methodology: https://510kreport.com/methodology