# K180838: SaliPen

- Pathway: 510(k) (Traditional)
- Applicant: Saliwell, Ltd.
- Decided: Nov 6, 2018 after 221 days
- Product code: LTF (Stimulator, Salivary 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: 2 generations back to P860067 (1988). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160799: GenNarino, Saliwell, Ltd. (2017) Summary page 4.

## Most influential descendants
- K220618: SaliPen (2022), 1 descendant of its own
- K232063: SaliPen (2023), 0 descendants of its own

## Indications for use
SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth), under prescription of a dental practitioner or physician.

Source page: https://510kreport.com/device/K180838
Methodology: https://510kreport.com/methodology