510(k) · Cleared
ClearedSlit Lamp SL-D301
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corporation · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Dec 9, 2016 as substantially equivalent to K133667 (Topcon Corp., 2014) after a 144-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Dec 9, 2016
- Review
- 144 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
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 backK133667 Slit Lamp SL-D701Topcon Corp. · 2014
- This deviceK161972 Slit Lamp SL-D301Topcon Corporation · 2016
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 | K133667 | Slit Lamp SL-D701 | Topcon Corp. | 2014 | — |
| 0 (this device) | K161972 | Slit Lamp SL-D301 | Topcon Corporation | 2016 | — |
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? (1)
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 |
|---|---|---|---|
| * | K133667 | Slit Lamp SL-D701Summary page 4…microscope Classification Name AC-powered slitlamp biomicroscope; 21 C.F.R. 886.1850 Class II Product Code: HJO Predicate Devices TOPCON CORPORATION Slit Lamp SL-D701 (K133667) Device Description This instrument is a slit lamp to observe, examine and photograph the eyeball and appendage of the eye. The… | 2014 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K133667.
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. 2016, 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?
The Slit Lamp SL-D301 is an AC-powered slitlamp biomicroscope intended for use in eye 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 trauma which affect the structural properties of the anterior eye segment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161972: Slit Lamp SL-D301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161972
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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