510(k) Report

510(k) · Cleared

Cleared

IN-Home Vision Monitoring Kit

K854047510(k) TraditionalCleared Dec 13, 198571-day reviewClass I21 CFR 886.1150

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

Rich-Larky Company, Inc. · HOX Chart, Visual Acuity

Cleared on Dec 13, 1985 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 13, 1985
Review
71 days
Class
Class I
Product code
HOX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K854047Source: 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 HOX devices

HOX Chart, Visual Acuity: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HOX

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HOX

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

Recalls per year · HOX

No recall names HOX since 2007.

Adverse event reports per year · HOX

1in 2018

2012: 12018: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code HOX, 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
20101—00
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in HOX

The HOX category page

  • K100095Central Vision Analyzer Model 1000Vimetrics,Llc. · 2010
  • K944156Heine Lambda 100Heine USA, Ltd. · 1995
  • K881971Occu-Tech Vision TestApplied Vision Concepts, Inc. · 1988
  • K883337PL 20/20 Infant Vision TesterOptimed Technologies, Inc. · 1988
  • K882634Visual Contrast Sensiti., Potential Acuity&GlareVistech Consultants, Inc. · 1988

https://510kreport.com/device/K854047 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854047: IN-Home Vision Monitoring Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854047

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