510(k) · Cleared
ClearedOoli-U (Tongue Scraper)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telefax Intl. · LCN Scraper, Tongue
Cleared on Mar 14, 1997 as substantially equivalent to K961574 (U.S. Dentek Corp., 1996) after a 67-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Mar 14, 1997
- Review
- 67 days
- Class
- Class I
- Product code
- LCN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961574 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961574 Tongue ScrapperU.S. Dentek Corp. · 1996
- This deviceK970042 Ooli-U (Tongue Scraper)Telefax Intl. · 1997
- Descendant · cites it directly · 0 of its ownK980842 Copper Tongue ScraperOntel Products Corp. · 1998
- Descendant · cites it directly · 0 of its ownK973424 Enfresh Tongue BrushEnfresh Products, LLC · 1997
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 | K961574 | Tongue Scrapper | U.S. Dentek Corp. | 1996 | — |
| 0 (this device) | K970042 | Ooli-U (Tongue Scraper) | Telefax Intl. | 1997 | — |
| +1 | K980842 | Copper Tongue Scraper | Ontel Products Corp. | 1998 | — |
| +1 | K973424 | Enfresh Tongue Brush | Enfresh Products, LLC | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 LCN? 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 |
|---|---|---|---|
| * | K961574 | Tongue ScrapperSummary page 1…14)-581-1448. 2. Proprietary Name: Ooli-U Common/Usual Name: Tongue Scraper/Tongue Cleaner Classification Name: Tongue Scraper 3. Predicate Device: U.S. Dentek’ Sakool (K961574). 4. Description of Device: The device is a formed piece of stainless steel. 5. Intended Use: The device is intended to remove pl… | 1996 |
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 LCN devicesLCN Scraper, Tongue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCN
FDA has decided no LCN device since 2007.
Median 510(k) review, days · LCN
Too few LCN 510(k)s in any year since 2007 to give a median.
Recalls per year · LCN
No recall names LCN since 2007.
Adverse event reports per year · LCN
1in 2024
MAUDE reports naming product code LCN, 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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is intended to remove plaque and food debris from the surface of the tongue.
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/K970042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970042: Ooli-U (Tongue Scraper).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970042
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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