510(k) Report

510(k) · Cleared

Cleared

Visual Contrast Sensiti., Potential Acuity&Glare

K882634510(k) TraditionalCleared Jul 15, 198818-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

Vistech Consultants, Inc. · HOX Chart, Visual Acuity

Cleared on Jul 15, 1988 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 15, 1988
Review
18 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 K882634Source: 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 HOX? 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 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—

More from Vistech Consultants, Inc.

7 FDA decisions under this applicant name. See the company

  • K881059MCT 8000 (Multi-Vision Contrast Tester)Vistech Consultants, Inc. · 1988
  • K881023VCTS 6500 SystemVistech Consultants, Inc. · 1988
  • K881021VCTS 700S SystemVistech Consultants, Inc. · 1988
  • K881022VCTS Marketing Program SystemVistech Consultants, Inc. · 1988
  • K853481Vistech VCTS Glare TesterVistech Consultants, Inc. · 1985

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
  • K881358PG Consen Contrast Sensitivity Testing ProgramNeuroscientific Corp. · 1988

https://510kreport.com/device/K882634 · printed Nov 4, 2026

Cite this page

510(k) Report. “K882634: Visual Contrast Sensiti., Potential Acuity&Glare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K882634

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