510(k) Report

510(k) · Cleared

Cleared

Landers Contact Lens

K802971510(k) TraditionalCleared Feb 5, 198176-day reviewClass I21 CFR 886.1395

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

Cooper Medical Devices Corp. · HJI Lens, Fundus, Hruby, Diagnostic

Cleared on Feb 5, 1981 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 5, 1981
Review
76 days
Class
Class I
Product code
HJI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K802971Source: 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 HJI? 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 HJI devices

HJI Lens, Fundus, Hruby, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJI

FDA has decided no HJI device since 2007.

Median 510(k) review, days · HJI

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

Recalls per year · HJI

No recall names HJI since 2007.

Adverse event reports per year · HJI

11in 2023

2021: 12023: 11
2007high 11 (2023) · low 0 (2007)2025

MAUDE reports naming product code HJI, 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—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—011
20240—00
20250—00
20260—0—

More from Cooper Medical Devices Corp.

7 FDA decisions under this applicant name. See the company

  • K802927Sebestyen Irrigating Contact LensCooper Medical Devices Corp. · 1981
  • K801850Charles Pneumatic Intraocular ScissorsCooper Medical Devices Corp. · 1980
  • K801411May Illuminated/Infusion PicCooper Medical Devices Corp. · 1980
  • K801312The ProtectorsCooper Medical Devices Corp. · 1980
  • K800833Vabra AspiratorCooper Medical Devices Corp. · 1980

Recent decisions in HJI

The HJI category page

  • K923670Byrne Expulsive LensOcular Instruments, Inc. · 1992
  • K90183960 Fundus Camera CF-60UVCanon USA, Inc. · 1990
  • K902138Stripe ProjectorAcademic Catalyst Corp. · 1990
  • K897186Laser Imaging Work StationInnovision Medical, Inc. · 1990
  • K820223Oms Quartz Infusion Contact LensOptical Micro Systems, Inc. · 1982

https://510kreport.com/device/K802971 · printed Nov 4, 2026

Cite this page

510(k) Report. “K802971: Landers Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K802971

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