510(k) Report

510(k) · Cleared

Cleared

Marco Models G,H and Primary Care Slit Lamps

K930438510(k) TraditionalCleared Aug 9, 1993195-day reviewClass II21 CFR 886.1850

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

Marco Ophthalmic, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered

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. 1 later device descends from it.

Decided
Aug 9, 1993
Review
195 days
Class
Class II
Product code
HJO
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared1990200020102020
  1. This deviceK930438 Marco Models G,H and Primary Care Slit LampsMarco Ophthalmic, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK060869 RS-1000 Zoom Slitlamp with OptionRightmedical Products, LLC · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K060869RS-1000 Zoom Slitlamp with OptionRightmedical Products, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930438Marco Models G,H and Primary Care Slit LampsMarco Ophthalmic, Inc.1993—
+1K060869RS-1000 Zoom Slitlamp with OptionRightmedical Products, LLC2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K930438, 1993–2006Source: FDA 510(k) summaries, read by 510(k) Report · 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 HJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HJO device

  1. #1 K253834 Visuref 600score 13.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060869RS-1000 Zoom Slitlamp with OptionRightmedical Products, LLC20060

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.

What does this lineage say?

  • Of its descendants, K060869 (Rightmedical Products, LLC, 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HJO devices

HJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJO

1in 2024

2007: 12008: 42009: 32010: 52011: 22013: 22014: 102015: 22016: 52017: 92018: 22020: 12022: 12024: 12026 (partial year): 2
2007high 10 (2014) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HJO

232in 2017

2008: 117 days median2009: 91 days median2010: 121 days median2014: 196 days median2016: 243 days median2017: 232 days median
2007high 243 (2016) · low 91 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HJO

1in 2018

2013: 22015: 22018: 1
2007high 2 (2013) · low 0 (2007)2026

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

Adverse event reports per year · HJO

20in 2025

2007: 12008: 32009: 32010: 22011: 52012: 72013: 162014: 42015: 82016: 152017: 152018: 112019: 132020: 192021: 142022: 62023: 182024: 182025: 20
2007high 20 (2025) · low 1 (2007)2025

MAUDE reports naming product code HJO, 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
20071—01
2008411703
200939103
2010512102
20112—05
20120—07
20132—216
20141019604
20152—28
20165243015
20179232015
20182—111
20190—013
20201—019
20210—014
20221—06
20230—018
20241—018
20250—020
20262—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
  • K930437Marco Standard RadiusgaugesMarco Ophthalmic, Inc. · 1993
  • K930439Marco Surgiscope Operation MicroscopesMarco Ophthalmic, Inc. · 1993

Recent decisions in HJO

The HJO category page

  • K262637SLIT LAMP SL-D4 (Type: LED)Topcon Corporation · 2026
  • K253834Visuref 600Carl Zeiss Vision GmbH · 2026
  • K231760HP-Oct (HP-Oct)Cylite Pty., Ltd. · 2024
  • K222372Kowa SL-19Kowa Company, Ltd. · 2022
  • K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020

https://510kreport.com/device/K930438 · printed Nov 3, 2026

Cite this page

510(k) Report. “K930438: Marco Models G,H and Primary Care Slit Lamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930438

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