510(k) · Cleared
ClearedGenNarino
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 Feb 17, 2017 as substantially equivalent to P860067 (Biosonics, Inc., 1988) after a 331-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.
- Decided
- Feb 17, 2017
- Review
- 331 days
- Class
- Class II
- Product code
- LTF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P860067 (1988). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP860067 Salitron SystemBiosonics, Inc. · 1988
- This deviceK160799 GenNarinoSaliwell, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK180838 SaliPenSaliwell, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK220618 SaliPenSaliwell, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK232063 SaliPenSaliwell, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P860067 | Salitron System | Biosonics, Inc. | 1988 | — |
| 0 (this device) | K160799 | GenNarino | Saliwell, Ltd. | 2017 | — |
| +1 | K180838 | SaliPen | Saliwell, Ltd. | 2018 | — |
| +2 | K220618 | SaliPen | Saliwell, Ltd. | 2022 | — |
| +2 | K232063 | SaliPen | Saliwell, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | P860067 | Salitron SystemSummary page 4…substantial equivalence: The legally marketed device to which GenNarino is compared for a determination regarding substantial equivalence is Salitron System, PMA Number P860067. This device is an electrical salivary stimulator system, recently classified as Class II (Federal Register /Vol. 80, No. 224 / F… | 1988 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180838 | SaliPen | 2018 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K180838 (Saliwell, Ltd., 2018) has gone furthest, with 2 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. 2017, 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?
GenNarino 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160799: GenNarino.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160799
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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