510(k) · Cleared
ClearedKlinly Ultrasonic Tongue Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kea Products, Ltd. · QIA Powered Tongue Scraper
Cleared on Sep 6, 2019 as substantially equivalent to K980075 (American Dentronics, Inc., 1998) after a 408-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Sep 6, 2019
- Review
- 408 days
- Class
- Class I
- Product code
- QIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980075 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980075 CybersonicAmerican Dentronics, Inc. · 1998
- This deviceK181986 Klinly Ultrasonic Tongue CleanerKea Products, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980075 | Cybersonic | American Dentronics, Inc. | 1998 | — |
| 0 (this device) | K181986 | Klinly Ultrasonic Tongue Cleaner | Kea Products, Ltd. | 2019 | — |
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 QIA? 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 |
|---|---|---|---|
| * | K980075 | CybersonicSummary page 4…Powered toothbrush Regulation Number: 21 CFR 872.6865 Product code: QIA Primary Predicate: • Cybersonic (K980075) American Dentronics, Incorporated. Reference Devices: • Unik Tongue Cleaner (K983683) Unik Products, Inc.… | 1998 |
| † | K983683 | Unik Tongue Cleaner | 1999 |
| † | K913724 | Sonex Ultrasonic Tooth Brush | 1992 |
| † | K040416 | Sonicare Advance Toothbrush, Model 4900 | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All QIA devicesQIA Powered Tongue Scraper: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QIA
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QIA
Too few QIA 510(k)s in any year since 2007 to give a median.
Recalls per year · QIA
No recall names QIA since 2007.
Adverse event reports per year · QIA
No MAUDE report names QIA 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181986: Klinly Ultrasonic Tongue Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181986
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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