510(k) · Cleared
ClearedKowa SC-1200 Photo Slit Lamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kowa Optimed, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jan 3, 1996 after a 36-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 34 later devices descend from it.
- Decided
- Jan 3, 1996
- Review
- 36 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 1 citing it directly.
- This deviceK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- Descendant · cites it directly · 33 of its ownK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- Descendant · 2 generations on · 18 of its ownK030719 Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003 · Recalled
- Descendant · 2 generations on · 18 of its ownK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- Descendant · 3 generations on · 16 of its ownK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- Descendant · 4 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K991284Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999 · cites it directly33descendants
- K030719Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003 · 2 generations on18descendants
- K012873Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001 · 2 generations on18descendants
- K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003 · 3 generations on16descendants
- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| +1 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| +2 | K030719 | Pentacam Scheimpflug Camera | Oculus Optikgerate GmbH | 2003 | 1 |
| +2 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| +3 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| +4 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.8 · 5 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? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991284 | Anterior Eye-Segment Analysis System | 1999 | 33 |
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, K991284 (Nidek, Inc., 1999) has gone furthest, with 33 descendants of its own.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K955442 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955442: Kowa SC-1200 Photo Slit Lamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955442
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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