510(k) Report

510(k) · Cleared

Cleared

Marco Standard Radiusgauges

K930437510(k) TraditionalCleared Aug 9, 1993195-day reviewClass I21 CFR 886.1430

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

Marco Ophthalmic, Inc. · HLF Device, Measuring, Lens Radius, Ophthalmic

Cleared on Aug 9, 1993 after a 195-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 9, 1993
Review
195 days
Class
Class I
Product code
HLF
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 K930437Source: 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 HLF devices

HLF Device, Measuring, Lens Radius, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLF

FDA has decided no HLF device since 2007.

Median 510(k) review, days · HLF

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

Recalls per year · HLF

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HLF

No MAUDE report names HLF 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—10
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—00
20250—00
20260—0—

More from Marco Ophthalmic, Inc.

15 FDA decisions under this applicant name. See the company

  • K943234MS-30 Automatic PerimeterMarco Ophthalmic, Inc. · 1994
  • K930444Marco Standard KeratometersMarco Ophthalmic, Inc. · 1993
  • K930442Marco GXX Series Photographic Slit LampsMarco Ophthalmic, Inc. · 1993
  • K930438Marco Models G,H and Primary Care Slit LampsMarco Ophthalmic, Inc. · 1993
  • K930439Marco Surgiscope Operation MicroscopesMarco Ophthalmic, Inc. · 1993

Recent decisions in HLF

The HLF category page

  • K862517Bausch & Lomb Contact Lens ViewerBausch & Lomb, Inc. · 1986
  • K823767Erg-Jet ElectrodeLife-Tech Intl., Inc. · 1983

https://510kreport.com/device/K930437 · printed Nov 5, 2026

Cite this page

510(k) Report. “K930437: Marco Standard Radiusgauges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K930437

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