510(k) · Cleared
ClearedTongue Scrapper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S. Dentek Corp. · LCN Scraper, Tongue
Cleared on Jun 10, 1996 after a 48-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 10, 1996
- Review
- 48 days
- Class
- Class I
- Product code
- LCN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK961574 Tongue ScrapperU.S. Dentek Corp. · 1996
- Descendant · cites it directly · 2 of its ownK970042 Ooli-U (Tongue Scraper)Telefax Intl. · 1997
- Descendant · cites it directly · 0 of its ownK980842 Copper Tongue ScraperOntel Products Corp. · 1998
- Descendant · 2 generations on · 0 of its ownK973424 Enfresh Tongue BrushEnfresh Products, LLC · 1997
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 |
|---|---|---|---|---|---|
| 0 (this device) | K961574 | Tongue Scrapper | U.S. Dentek Corp. | 1996 | — |
| +1 | K970042 | Ooli-U (Tongue Scraper) | Telefax Intl. | 1997 | — |
| +1 | K980842 | Copper Tongue Scraper | Ontel Products Corp. | 1998 | — |
| +2 | K973424 | Enfresh Tongue Brush | Enfresh Products, LLC | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K970042 (Telefax Intl., 1997) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K961574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961574: Tongue Scrapper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961574
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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