510(k) Report

510(k) · Cleared

Cleared

Bite Stick

K821177510(k) TraditionalCleared May 21, 198224-day reviewClass I21 CFR 880.6230

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

Abco Dealers, Inc. · FMA Depressor, Tongue, Non-Surgical

Cleared on May 21, 1982 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 21, 1982
Review
24 days
Class
Class I
Product code
FMA
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K821177Source: 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), 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.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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 FMA devices

FMA 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

2009: 12016: 22020: 32021: 12023: 2
2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code FMA, 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—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—02
20170—00
20180—00
20190—00
20200—03
20210—01
20220—00
20230—02
20240—00
20250—00
20260—0—

More from Abco Dealers, Inc.

127 FDA decisions under this applicant name. See the company

  • K905025Digital Thermometer KitsAbco Dealers, Inc. · 1991
  • K882304Digital Thermometer Sheaths (Oral and Rectal)Abco Dealers, Inc. · 1988
  • K880892Blood Collecting Needle and HoldersAbco Dealers, Inc. · 1988
  • K880894Allergist SyringesAbco Dealers, Inc. · 1988
  • K872875Stretch Gauze BandagesAbco Dealers, Inc. · 1987

Recent decisions in FMA

The FMA category page

  • K992995Aromatic and Flavored Tongue DepressorAga Plastic Ind. Com. Ltda. · 1999
  • K842461Tongue DepressorThe Torrent Corp. · 1984
  • K830705Mini Lancet-Blood LancetPharmaquest Corp. · 1983
  • K770120Mouth Wash TrayPharmaseal Div., Baxter Healthcare Corp. · 1977

https://510kreport.com/device/K821177 · printed Nov 6, 2026

Cite this page

510(k) Report. “K821177: Bite Stick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821177

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026