510(k) · Cleared
ClearedSaliPen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saliwell, Ltd. · QTT Over The Counter Electrical Salivary Stimulatory System
Cleared on Dec 13, 2023 as substantially equivalent to K180838 (Saliwell, Ltd., 2018) and 1 other predicate after a 155-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Dec 13, 2023
- Review
- 155 days
- Class
- Class II
- Product code
- QTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P860067 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QTT device
- #1 K220618 SaliPenscore 7.5 · 3 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180838 | SaliPenSummary page 5…system Classification name: Electrical salivary stimulator system Regulatory Class: II Product Code: QTT III. PREDICATE DEVICE The predicate devices are SaliPen K180838 and K220618. IV. DEVICE DESCRIPTION SaliPen is an electrical salivary stimulatory system device. It is comprised of two… | 2018 |
| * | K220618 | SaliPenSummary page 5…sification name: Electrical salivary stimulator system Regulatory Class: II Product Code: QTT III. PREDICATE DEVICE The predicate devices are SaliPen K180838 and K220618. IV. DEVICE DESCRIPTION SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an in… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K180838.
How does its category compare?
All QTT devicesQTT Over The Counter Electrical Salivary Stimulatory System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QTT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QTT
Too few QTT 510(k)s in any year since 2007 to give a median.
Recalls per year · QTT
No recall names QTT since 2007.
Adverse event reports per year · QTT
No MAUDE report names QTT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232063: SaliPen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232063
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026