510(k) Report

510(k) · Cleared

Cleared

Illuminated Speculum

K801058510(k) TraditionalCleared May 28, 198022-day reviewClass I21 CFR 878.1800

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

Designs For Vision, Inc. · FXF Speculum, Illuminated

Cleared on May 28, 1980 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 28, 1980
Review
22 days
Class
Class I
Product code
FXF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801058Source: 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 FXF? 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 FXF devices

FXF Speculum, Illuminated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXF

FDA has decided no FXF device since 2007.

Median 510(k) review, days · FXF

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

Recalls per year · FXF

No recall names FXF since 2007.

Adverse event reports per year · FXF

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code FXF, 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—00
20220—00
20230—00
20240—01
20250—00
20260—0—

More from Designs For Vision, Inc.

5 FDA decisions under this applicant name. See the company

  • K051786Melide Fiberoptic LightDesigns For Vision, Inc. · 2005
  • K043530Dvi Curing LightDesigns For Vision, Inc. · 2005
  • K032283Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
  • K013880Daylite Xenon Light SourcesDesigns For Vision, Inc. · 2001

https://510kreport.com/device/K801058 · printed Nov 5, 2026

Cite this page

510(k) Report. “K801058: Illuminated Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K801058

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