510(k) Report

510(k) · Cleared

Cleared

Bacti-Stop Toothbrush Cleaner and Sanitizer

K992435510(k) TraditionalCleared Oct 15, 199985-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

Azo Enterprises · EFW Toothbrush, Manual

Cleared on Oct 15, 1999 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Oct 15, 1999
Review
85 days
Class
Class I
Product code
EFW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K992435Source: 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.

Planning a device in EFW? 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
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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 EFW devices

EFW Toothbrush, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFW

1in 2013

2008: 12011: 12012: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFW

Too few EFW 510(k)s in any year since 2007 to give a median.

Recalls per year · EFW

No recall names EFW since 2007.

Adverse event reports per year · EFW

71in 2025

2007: 62008: 102009: 92010: 22011: 132012: 1452013: 602014: 232015: 482016: 352017: 682018: 1092019: 1152020: 1132021: 1202022: 3272023: 992024: 872025: 71
2007high 327 (2022) · low 2 (2010)2025

MAUDE reports naming product code EFW, 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—06
20081—010
20090—09
20100—02
20111—013
20121—0145
20131—060
20140—023
20150—048
20160—035
20170—068
20180—0109
20190—0115
20200—0113
20210—0120
20220—0327
20230—099
20240—087
20250—071
20260—0—

What is it indicated for?

This device is intended to clean and sanitize toothbrushes before and after normal oral use.

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 EFW

The EFW category page

  • K130186Dentek Easy Brush with FluorideDen Tek Oral Care, Inc. · 2013
  • K121165Beam Brush/Beam AppBeam Technologies, LLC · 2012
  • K102871Silver Care Anitbacterial ToothbrushPiave Spazzolificio S.P.A. · 20111 recall
  • K073224Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008
  • K021383Zeodyne Toothbrush with Agion AntimicrobialAgion Technologies, LLC · 2002

https://510kreport.com/device/K992435 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992435: Bacti-Stop Toothbrush Cleaner and Sanitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992435

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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