510(k) Report

510(k) · Cleared

Cleared

Keeler Dual Lightsource

K861746510(k) TraditionalCleared Aug 21, 1986107-day reviewClass II21 CFR 886.4335

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

Keeler Instruments, Inc. · HPQ Headlamp, Operating, Ac-Powered

Cleared on Aug 21, 1986 after a 107-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 21, 1986
Review
107 days
Class
Class II
Product code
HPQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K861746Source: 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 HPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 HPQ devices

HPQ Headlamp, Operating, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPQ

FDA has decided no HPQ device since 2007.

Median 510(k) review, days · HPQ

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

Recalls per year · HPQ

No recall names HPQ since 2007.

Adverse event reports per year · HPQ

No MAUDE report names HPQ since 2007.

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—00
20240—00
20250—00
20260—0—

More from Keeler Instruments, Inc.

60 FDA decisions under this applicant name. See the company

  • K181143Keeler TonoCare TonometerKeeler Instruments, Inc. · 2019
  • K112093Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterKeeler Instruments, Inc. · 2011
  • K093298Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000Keeler Instruments, Inc. · 2010
  • K100500PSL Classic Slit LampKeeler Instruments, Inc. · 2010
  • K062412CryomaticKeeler Instruments, Inc. · 2006

Recent decisions in HPQ

The HPQ category page

  • K952289Welch Allyn Fiber Optic HeadligntWelch Allyn, Inc. · 1995
  • K951337Fiber Head Light FH-300Neitz Instruments Company, Ltd. · 1995
  • K861747Keeler Fiberoptic HeadlampKeeler Instruments, Inc. · 1986
  • K822272Head Mirrors W/Head Lamps & Head BandsKelleher Corp. · 1982

https://510kreport.com/device/K861746 · printed Nov 4, 2026

Cite this page

510(k) Report. “K861746: Keeler Dual Lightsource.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861746

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