510(k) · Cleared
ClearedSaliPen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saliwell, Ltd. · LTF Stimulator, Salivary System
Cleared on Nov 6, 2018 as substantially equivalent to K160799 (Saliwell, Ltd., 2017) after a 221-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Nov 6, 2018
- Review
- 221 days
- Class
- Class II
- Product code
- LTF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P860067 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP860067 Salitron SystemBiosonics, Inc. · 1988
- 1 generation backK160799 GenNarinoSaliwell, Ltd. · 2017
- This deviceK180838 SaliPenSaliwell, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK220618 SaliPenSaliwell, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK232063 SaliPenSaliwell, Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P860067 | Salitron System | Biosonics, Inc. | 1988 | — |
| −1 | K160799 | GenNarino | Saliwell, Ltd. | 2017 | — |
| 0 (this device) | K180838 | SaliPen | Saliwell, Ltd. | 2018 | — |
| +1 | K220618 | SaliPen | Saliwell, Ltd. | 2022 | — |
| +1 | K232063 | SaliPen | Saliwell, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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 LTF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K160799 | GenNarinoSummary page 4…system Classification name: Electrical salivary stimulator system Regulatory Class: II Product Code: LTF III. PREDICATE DEVICE The predicate device is GenNarino, K160799. IV. DEVICE DESCRIPTION SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an in… | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 2 companies; a new generation was cleared every 28.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220618 (Saliwell, Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LTF devicesLTF Stimulator, Salivary System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LTF
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LTF
Too few LTF 510(k)s in any year since 2007 to give a median.
Recalls per year · LTF
No recall names LTF since 2007.
Adverse event reports per year · LTF
1in 2023
MAUDE reports naming product code LTF, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 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), under prescription of a dental practitioner or physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180838: SaliPen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180838
Report an extraction error
Are you the manufacturer?
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