510(k) Report

510(k) · Cleared

Cleared

Breathtique Tongue Scraper

K983087510(k) TraditionalCleared Nov 18, 199876-day reviewClass I21 CFR 872.6855

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Custom Medical Arts, Inc. · LCN Scraper, Tongue

Cleared on Nov 18, 1998 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Nov 18, 1998
Review
76 days
Class
Class I
Product code
LCN
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K983087Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All LCN devices

LCN 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

2024: 1
2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code LCN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The Breathtique Tongue Scraper is intended to be used to remove bacterial plaque and food debris from the surface of the tongue.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Recent decisions in LCN

The LCN category page

  • K992270Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999
  • K990344Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999
  • K983683Unik Tongue CleanerUnik Products, Inc. · 1999
  • K981808Breathaid Tongue ScraperBreathaid, LLC · 1998
  • K980842Copper Tongue ScraperOntel Products Corp. · 1998

https://510kreport.com/device/K983087 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983087: Breathtique 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/K983087

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026