510(k) · Cleared
ClearedHydris™ Oral Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopharm Consult, LLC · LFD Saliva, Artificial
Cleared on Jun 19, 2017 as substantially equivalent to K123731 (Glaxosmithkline Consumer Healthcare (Gskch), 2013) after a 231-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.
- Decided
- Jun 19, 2017
- Review
- 231 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123731 (2013). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013 · Recalled
- This deviceK163029 Hydris™ Oral RinseBiopharm Consult, LLC · 2017
- Descendant · cites it directly · 0 of its ownK190144 MucoPEGSunbio, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK181194 SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −1 | K123731 | Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing… | Glaxosmithkline Consumer Healthcare (Gskch) | 2013 | 1 |
| 0 (this device) | K163029 | Hydris™ Oral Rinse | Biopharm Consult, LLC | 2017 | — |
| +1 | K190144 | MucoPEG | Sunbio, Inc. | 2019 | — |
| +1 | K181194 | SmartMouth DryMouth Oral Rinse | Triumph Pharmaceuticals, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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 LFD? 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 LFD device
- #1 K253778 Allday Moisturizing Rinsescore 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K123731 | Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth SpraySummary page 4…LFD Review Panel Dental Devices Panel Primary Predicate Device The predicate device for this submission is Biotene® Dry Mouth Oral Rinse (K123731), cleared on January 4, 2013. The primary predicate is one of three Biotene dry mouth products cleared in K123731 which contains… | 2013 |
| † | K152201 | MedActive Oral Gel and Spray | 2015 |
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?
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LFD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFD
287in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFD
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFD
11in 2025
MAUDE reports naming product code LFD, 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 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 3 | 83 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 209 | 0 | 5 |
| 2012 | 2 | — | 0 | 7 |
| 2013 | 2 | — | 1 | 37 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 5 | 156 | 0 | 28 |
| 2016 | 0 | — | 0 | 68 |
| 2017 | 3 | 231 | 0 | 51 |
| 2018 | 5 | 210 | 0 | 37 |
| 2019 | 3 | 287 | 0 | 40 |
| 2020 | 1 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 2 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
“Relieves the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation and lubricate oral dryness.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163029: Hydris™ Oral Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163029
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