510(k) · Cleared
ClearedMarco Ultra M3, Marco Ultra M4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Takagi Seiko Co., Ltd. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Apr 14, 2017 as substantially equivalent to K100202 (Haag-Streit AG, 2010) and 1 other predicate after a 205-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Apr 14, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982057 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK982057 BC 900 Slit LampHaag-Streit AG · 1998
- 3 generations backK100202 Slit Lamp BO 900, BQ 900, BP900Haag-Streit AG · 2010
- 2 generations backK110489 Slit Lamp SL-2GTopcon Medical Systems, Inc. · 2011
- 1 generation backK152535 Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. · 2016
- This deviceK162636 Marco Ultra M3, Marco Ultra M4Takagi Seiko Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982057 | BC 900 Slit Lamp | Haag-Streit AG | 1998 | — |
| −3 | K100202 | Slit Lamp BO 900, BQ 900, BP900 | Haag-Streit AG | 2010 | — |
| −2 | K110489 | Slit Lamp SL-2G | Topcon Medical Systems, Inc. | 2011 | — |
| −1 | K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | 2016 | — |
| 0 (this device) | K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | 2017 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K253834 Visuref 600score 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100202 | Slit Lamp BO 900, BQ 900, BP900Summary page 5…Manufacture: Haag-Streit AG Device name: Slit Lamp BM900 510(k) Premarket Notification No: K100202 Classification name: Biomicroscope, Slit-Lamp, AC-Powered CFR title:… | 2010 |
| * | K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscopeSummary page 5…TAKAGI SEIKO CO., LTD Device name: Z2 Slit lamp microscope 510(k) Premarket Notification No: K152535 Classification name: Biomicroscope, Slit-Lamp, AC-Powered CFR title:… | 2016 |
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.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K100202.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment,
from the cornea epithelium to the posterior capsule.
It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162636: Marco Ultra M3, Marco Ultra M4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162636
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026