510(k) Report

510(k) · Cleared

Cleared

Corneal Topographer 200

K963762510(k) TraditionalCleared Dec 23, 199695-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

Eclipse Ventures · MMQ Topographer, Corneal, Ac-Powered

Cleared on Dec 23, 1996 after a 95-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 23, 1996
Review
95 days
Class
Class I
Product code
MMQ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K963762Source: 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 lists a 510(k) statement for it but has not posted the file, 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 MMQ devices

MMQ Topographer, Corneal, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MMQ

FDA has decided no MMQ device since 2007.

Median 510(k) review, days · MMQ

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

Recalls per year · MMQ

No recall names MMQ since 2007.

Adverse event reports per year · MMQ

1in 2025

2012: 12014: 12017: 32019: 22020: 12025: 1
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code MMQ, 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—01
20130—00
20140—01
20150—00
20160—00
20170—03
20180—00
20190—02
20200—01
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

Recent decisions in MMQ

The MMQ category page

  • K981665Silon Topomat Corneal Topography Image Enhancement DeviceBio-Medical Sciences, Inc. · 1998
  • K964702Euclid Systems Corneal Topographer Model ET800Euclid Systems Corp. · 1997
  • K964891Orbshot KeratometerOrbtek, Inc. · 1997
  • K950077Intraoperative Corneal Topography System (I-CTS)Par Vision Systems Corp. · 1995

https://510kreport.com/device/K963762 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963762: Corneal Topographer 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963762

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