510(k) Report

510(k) · Cleared

Cleared

Kreda Disc

K874252510(k) TraditionalCleared Jan 27, 1988100-day reviewClass I21 CFR 886.1330

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

Richmond Products, Inc. · HOQ Grid, Amsler

Cleared on Jan 27, 1988 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 27, 1988
Review
100 days
Class
Class I
Product code
HOQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K874252Source: 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 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 HOQ devices

HOQ Grid, Amsler: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HOQ

1in 2018

2013: 12015: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HOQ

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

Recalls per year · HOQ

No recall names HOQ since 2007.

Adverse event reports per year · HOQ

No MAUDE report names HOQ since 2007.

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
20131—00
20140—00
20151—00
20160—00
20170—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K874252: Kreda Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874252

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