510(k) Report

510(k) · Cleared

Cleared

Plaque Detection System

K781919510(k) TraditionalCleared Dec 4, 197821-day reviewClass II21 CFR 872.1740

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

Clairol, Inc. · NYH Plaque Disclosing Kit

Cleared on Dec 4, 1978 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 4, 1978
Review
21 days
Class
Class II
Product code
NYH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K781919Source: 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 NYH? 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 NYH devices

NYH Plaque Disclosing Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NYH

FDA has decided no NYH device since 2007.

Median 510(k) review, days · NYH

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

Recalls per year · NYH

No recall names NYH since 2007.

Adverse event reports per year · NYH

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code NYH, 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—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Clairol, Inc.

4 FDA decisions under this applicant name. See the company

  • K852604Muscle Minder: Heat Wrap W/ Hot + Cold PackClairol, Inc. · 1985
  • K772087Ultrasonic Denture CleanerClairol, Inc. · 1977
  • K770368Oral IrrigatorClairol, Inc. · 1977

https://510kreport.com/device/K781919 · printed Nov 6, 2026

Cite this page

510(k) Report. “K781919: Plaque Detection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781919

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