510(k) · Cleared
ClearedSlit Lamp, Models HS-5000, HS-5500 and HS-7500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huvitz Co., Ltd. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Dec 3, 2009 as substantially equivalent to K073190 (Huvitz Co., Ltd., 2008) after a 9-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Dec 3, 2009
- Review
- 9 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992836 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K073190 | Slit LampSummary page 1…: Slilt Lamnp Classification Name AC:Powered Slitlamp Biomicroscope 3. Predicate Devices: Manufacturer; Hluvitz Co.:Ltd+ Device: HS-5000 510(k) Number: K(073190 (Decision Date - Jan.'11. 2008) 4, Classifications Names & Citations: 21 CFR 886.1850, HJO - AC-Powered Slitlamnp Biomicrosc… | 2008 |
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 10 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
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. 2009, 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 Lamps HS-5500, HS-7000, HS-7500 are 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/K093639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093639: Slit Lamp, Models HS-5000, HS-5500 and HS-7500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093639
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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