510(k) Report

510(k) · Cleared

Cleared

Ect-100 Electronic Corneal Topographer

K890687510(k) TraditionalCleared Sep 5, 1989208-day reviewClass I21 CFR 886.1350

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

Optimed, Inc. · HLQ Keratoscope, Ac-Powered

Cleared on Sep 5, 1989 after a 208-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 5, 1989
Review
208 days
Class
Class I
Product code
HLQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890687Source: 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 HLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 HLQ devices

HLQ Keratoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLQ

FDA has decided no HLQ device since 2007.

Median 510(k) review, days · HLQ

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

Recalls per year · HLQ

No recall names HLQ since 2007.

Adverse event reports per year · HLQ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code HLQ, 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—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Optimed, Inc.

4 FDA decisions under this applicant name. See the company

  • K903462Optimed Glaucoma Pressure RegulatorOptimed, Inc. · 1990
  • K884867Optifield I and II Automated PerimetersOptimed, Inc. · 1989
  • K883458Optimed AdvantageOptimed, Inc. · 1988

Recent decisions in HLQ

The HLQ category page

  • K003299Opd-Scan, Models Ark-10000 and Ark-9000Nidek Co., Ltd. · 2001
  • K973756Eye Sys VistaEyesys Technologies, Inc. · 1997
  • K964290EyechekReichert Ophthalmic Instruments, Div. Leica, Inc. · 1997
  • K945382Technomed C-Scan Color Ellipsoid TopometerExpertech Assoc., Inc. · 1995
  • K944207Topographic Modeling System 2 TMS-2Computed Anatomy, Inc. · 1994

https://510kreport.com/device/K890687 · printed Nov 5, 2026

Cite this page

510(k) Report. “K890687: Ect-100 Electronic Corneal Topographer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890687

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