510(k) · Cleared
ClearedPortable Slit Lamp Microscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Kangjie Medical, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Jul 21, 2017 as substantially equivalent to K131711 (Suzhou 66 Vision Tech Co., Ltd., 2014) after a 294-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Jul 21, 2017
- Review
- 294 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K131711 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK131711 YZ3 Portable Slit LampSuzhou 66 Vision Tech Co., Ltd. · 2014
- This deviceK162778 Portable Slit Lamp MicroscopeSuzhou Kangjie Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K131711 | YZ3 Portable Slit Lamp | Suzhou 66 Vision Tech Co., Ltd. | 2014 | — |
| 0 (this device) | K162778 | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | 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? (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 |
|---|---|---|---|
| * | K131711 | YZ3 Portable Slit LampSummary page 4…e Class: II Classification Name: AC-Powered Slitlamp Biomicroscope Regulation Number: 21 CFR 886.1850 Product Code: HJO Review Panel: Ophthalmic Predicate Device: • K131711, SUZHOU 66 VISION TECH CO., LTD YZ3 PORTABLE SLIT LAMP Device Description: Portable Slit Lamp Microscope Model KJ5S The Po… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K131711.
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?
Portable Slit Lamp Microscope Model KJ5S is intended for use in the examination of the anterior and posterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162778: Portable Slit Lamp Microscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162778
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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