510(k) Report

510(k) · Cleared

Cleared

Count-10 Stain

K823363510(k) TraditionalCleared Dec 15, 198236-day reviewClass I21 CFR 864.1850

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

V-Tech, Inc. · LEE Stains, Dye Solution

Cleared on Dec 15, 1982 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 15, 1982
Review
36 days
Class
Class I
Product code
LEE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823363Source: 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 LEE? 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 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 LEE devices

LEE Stains, Dye Solution: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LEE

FDA has decided no LEE device since 2007.

Median 510(k) review, days · LEE

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

Recalls per year · LEE

No recall names LEE since 2007.

Adverse event reports per year · LEE

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code LEE, 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—01
20240—00
20250—00
20260—0—

More from V-Tech, Inc.

22 FDA decisions under this applicant name. See the company

  • K914303Target (TM)-HogV-Tech, Inc. · 1991
  • K910893Target (TM) Cannabinoids-R TestV-Tech, Inc. · 1991
  • K910892Target (TM) Cannabinoids-V TestV-Tech, Inc. · 1991
  • K910739Target Amphetamine/Methamphetamine-R (Reader Meth)V-Tech, Inc. · 1991
  • K910123Target Cocaine Metabolite-VV-Tech, Inc. · 1991

https://510kreport.com/device/K823363 · printed Nov 6, 2026

Cite this page

510(k) Report. “K823363: Count-10 Stain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K823363

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