PMA · Approved
ApprovedSalitron System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosonics, Inc. · LTF Stimulator, Salivary System
Approved on May 17, 1988 through premarket approval, which rests on the device’s own clinical evidence after a 515-day review. 4 later devices descend from it.
- Decided
- May 17, 1988
- Review
- 515 days
- Class
- Class II
- Product code
- LTF
- Recalls
- None
4 later devices descend from it, 1 citing it directly.
- This deviceP860067 Salitron SystemBiosonics, Inc. · 1988
- Descendant · cites it directly · 3 of its ownK160799 GenNarinoSaliwell, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK180838 SaliPenSaliwell, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK220618 SaliPenSaliwell, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK232063 SaliPenSaliwell, Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P860067 | Salitron System | Biosonics, Inc. | 1988 | — |
| +1 | K160799 | GenNarino | Saliwell, Ltd. | 2017 | — |
| +2 | K180838 | SaliPen | Saliwell, Ltd. | 2018 | — |
| +3 | K220618 | SaliPen | Saliwell, Ltd. | 2022 | — |
| +3 | K232063 | SaliPen | Saliwell, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160799 | GenNarino | 2017 | 3 |
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?
- Of its descendants, K160799 (Saliwell, Ltd., 2017) has gone furthest, with 3 descendants 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.
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 | — |
https://510kreport.com/device/P860067 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860067: Salitron System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860067
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026