510(k) · Cleared
ClearedKowa Portable Slit Lamp SL-14 & SL-14B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kowa Optimed, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Nov 24, 1995 after a 38-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 24, 1995
- Review
- 38 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK954782 Kowa Portable Slit Lamp SL-14 & SL-14BKowa Optimed, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK063640 Kowa SL-15Kowa Co., Ltd. · 2006
- Descendant · 2 generations on · 1 of its ownK170470 Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2017
- Descendant · 2 generations on · 1 of its ownK133755 Kowa SL-17Kowa Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK222372 Kowa SL-19Kowa Company, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK193188 MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K063640Kowa SL-15Kowa Co., Ltd. · 2006 · cites it directly5descendants
- K170470Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2017 · 2 generations on1descendant
- K133755Kowa SL-17Kowa Co., Ltd. · 2014 · 2 generations on1descendant
- K222372Kowa SL-19Kowa Company, Ltd. · 2022 · 3 generations on0descendants
- K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954782 | Kowa Portable Slit Lamp SL-14 & SL-14B | Kowa Optimed, Inc. | 1995 | — |
| +1 | K063640 | Kowa SL-15 | Kowa Co., Ltd. | 2006 | — |
| +2 | K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017 | — |
| +2 | K133755 | Kowa SL-17 | Kowa Co., Ltd. | 2014 | — |
| +3 | K222372 | Kowa SL-19 | Kowa Company, Ltd. | 2022 | — |
| +3 | K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K063640 (Kowa Co., Ltd., 2006) has gone furthest, with 5 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K954782 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954782: Kowa Portable Slit Lamp SL-14 & SL-14B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954782
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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