510(k) · Cleared
ClearedTongue Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jack Conrey · LCN Scraper, Tongue
Cleared on May 31, 1996 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 31, 1996
- Review
- 31 days
- Class
- Class I
- Product code
- LCN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK961660 Tongue CleanerJack Conrey · 1996
- Descendant · cites it directly · 3 of its ownK972644 Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK983683 Unik Tongue CleanerUnik Products, Inc. · 1999
- Descendant · 3 generations on · 0 of its ownK992270 Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK990344 Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999
Most influential descendants
Showing 4 of 4 · See all- K972644Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997 · cites it directly3descendants
- K983683Unik Tongue CleanerUnik Products, Inc. · 1999 · 2 generations on1descendant
- K992270Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999 · 3 generations on0descendants
- K990344Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961660 | Tongue Cleaner | Jack Conrey | 1996 | — |
| +1 | K972644 | Breath-SO-Fresh Tongue Cleaner | Intl. Dental Design Specialists, Inc. | 1997 | — |
| +2 | K983683 | Unik Tongue Cleaner | Unik Products, Inc. | 1999 | — |
| +3 | K992270 | Miraclebreath Tongue Cleaner | Stellar Labs, Inc. | 1999 | — |
| +2 | K990344 | Oralgiene Tongue Cleaner | Oralgiene USA, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972644 | Breath-SO-Fresh Tongue Cleaner | 1997 | 3 |
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, K972644 (Intl. Dental Design Specialists, Inc., 1997) has gone furthest, with 3 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/K961660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961660: Tongue Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961660
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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