510(k) Report

510(k) · Cleared

Cleared

Sensory 6

K862338510(k) TraditionalCleared Sep 3, 198675-day reviewClass I21 CFR 886.5900

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

Brytech, Inc. · HPG Aid, Vision, Electronic, Battery-Powered

Cleared on Sep 3, 1986 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 3, 1986
Review
75 days
Class
Class I
Product code
HPG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K862338Source: 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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  • 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 HPG devices

HPG Aid, Vision, Electronic, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPG

FDA has decided no HPG device since 2007.

Median 510(k) review, days · HPG

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

Recalls per year · HPG

No recall names HPG since 2007.

Adverse event reports per year · HPG

No MAUDE report names HPG 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—

Recent decisions in HPG

The HPG category page

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  • K903558Laser CaneNurion Industries · 1990
  • K902187PolaronNurion Industries · 1990
  • K823385ALESOms · 1983

https://510kreport.com/device/K862338 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862338: Sensory 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862338

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