510(k) · Cleared
ClearedAromatic and Flavored Tongue Depressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aga Plastic Ind. Com. Ltda. · FMA Depressor, Tongue, Non-Surgical
Cleared on Dec 9, 1999 as substantially equivalent to K842461 (The Torrent Corp., 1984) after a 93-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 9, 1999
- Review
- 93 days
- Class
- Class I
- Product code
- FMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K842461 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK842461 Tongue DepressorThe Torrent Corp. · 1984
- This deviceK992995 Aromatic and Flavored Tongue DepressorAga Plastic Ind. Com. Ltda. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842461 | Tongue Depressor | The Torrent Corp. | 1984 | — |
| 0 (this device) | K992995 | Aromatic and Flavored Tongue Depressor | Aga Plastic Ind. Com. Ltda. | 1999 | — |
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 FMA? 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 |
|---|---|---|---|
| * | K842461 | Tongue DepressorSummary page 1…21 260-5753 Fax: 5521 266-5130 Name of the Device: Aromatic and Flavored Tongue Depressor Predicate Device Information: The Torrent Corporation, Tongue Depressor, K# 842461 Device Description: The Aromatic and Flavored Tongue Depressor is for medical use which is comprised of a non-toxic thermoplast… | 1984 |
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 FMA devicesFMA Depressor, Tongue, Non-Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMA
FDA has decided no FMA device since 2007.
Median 510(k) review, days · FMA
Too few FMA 510(k)s in any year since 2007 to give a median.
Recalls per year · FMA
No recall names FMA since 2007.
Adverse event reports per year · FMA
2in 2023
MAUDE reports naming product code FMA, 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 | 1 |
| 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 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aromatic and Flavored Tongue Depressor is intended to displace the tongue to facilitate examination of the surrounding organs. They are available in the following colors: Ycllow. blue. orange, magenta. pink. green and red.
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/K992995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992995: Aromatic and Flavored Tongue Depressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992995
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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