510(k) Report

510(k) · Cleared

Cleared

Ful-Vue

K782118510(k) TraditionalCleared Jan 26, 197930-day reviewClass I21 CFR 886.1770

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

American Optical Corp. · HKN Refractor, Manual, Non-Powered, Including Phoropter

Cleared on Jan 26, 1979 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 26, 1979
Review
30 days
Class
Class I
Product code
HKN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K782118Source: 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 HKN? 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 HKN devices

HKN Refractor, Manual, Non-Powered, Including Phoropter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HKN

FDA has decided no HKN device since 2007.

Median 510(k) review, days · HKN

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

Recalls per year · HKN

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HKN

1in 2022

2013: 12014: 142015: 32016: 12017: 192022: 1
2007high 19 (2017) · low 0 (2007)2025

MAUDE reports naming product code HKN, 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
20100—00
20110—00
20120—00
20130—01
20140—014
20150—03
20160—01
20170—019
20180—10
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from American Optical Corp.

35 FDA decisions under this applicant name. See the company

  • K950881Phaco TipAmerican Optical Corp. · 1995
  • K950880Aoi Universal Ultrasonic HandpieceAmerican Optical Corp. · 1995
  • K931354P4000 PhacoemulsifierAmerican Optical Corp. · 1994
  • K931358AORP4000 Reusable PakAmerican Optical Corp. · 1994
  • K931357AOD4000 Disposable PakAmerican Optical Corp. · 1994

Recent decisions in HKN

The HKN category page

  • K936205Comprehensive Phoropter, MDR-680Canon USA, Inc. · 1994
  • K874900Woodlyn Classic Refractor, PhoroptorWoodlyn, Inc. · 1987

https://510kreport.com/device/K782118 · printed Nov 5, 2026

Cite this page

510(k) Report. “K782118: Ful-Vue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K782118

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