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 Aug 30, 2022 as substantially equivalent to K180838 (Saliwell, Ltd., 2018) after a 180-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Aug 30, 2022
- Review
- 180 days
- Class
- Class II
- Product code
- QTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P860067 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP860067 Salitron SystemBiosonics, Inc. · 1988
- 2 generations backK160799 GenNarinoSaliwell, Ltd. · 2017
- 1 generation backK180838 SaliPenSaliwell, Ltd. · 2018
- This deviceK220618 SaliPenSaliwell, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK232063 SaliPenSaliwell, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232063SaliPenSaliwell, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P860067 | Salitron System | Biosonics, Inc. | 1988 | — |
| −2 | K160799 | GenNarino | Saliwell, Ltd. | 2017 | — |
| −1 | K180838 | SaliPen | Saliwell, Ltd. | 2018 | — |
| 0 (this device) | K220618 | SaliPen | Saliwell, Ltd. | 2022 | — |
| +1 | K232063 | SaliPen | Saliwell, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 K232063 SaliPenscore 7.4 · 4 generations · no Class I recall
What was it cleared against? (1)
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 4…r system Classification name: Electrical salivary stimulator system Regulatory Class: II Product Code: QTT III. PREDICATE DEVICE The predicate device is SaliPen, K180838. IV. DEVICE DESCRIPTION SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an in… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232063 | SaliPen | 2023 | 0 |
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 34 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232063 (Saliwell, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2022, 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/K220618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220618: SaliPen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220618
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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