510(k) Report

510(k) · Cleared

Cleared

Sunsor Ultraviolet Meter

K934728510(k) TraditionalCleared Jul 28, 1994302-day reviewClass II21 CFR 872.6350

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

Sunsor, Inc. · EAQ Detector, Ultraviolet

Cleared on Jul 28, 1994 after a 302-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 28, 1994
Review
302 days
Class
Class II
Product code
EAQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K934728Source: 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.

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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 EAQ devices

EAQ Detector, Ultraviolet: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EAQ

FDA has decided no EAQ device since 2007.

Median 510(k) review, days · EAQ

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

Recalls per year · EAQ

No recall names EAQ since 2007.

Adverse event reports per year · EAQ

No MAUDE report names EAQ 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—
Cite this page

510(k) Report. “K934728: Sunsor Ultraviolet Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934728

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