510(k) · Cleared
ClearedNidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 4, 1997 after a 47-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 37 later devices descend from it.
- Decided
- Nov 4, 1997
- Review
- 47 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 2 citing it directly.
- This deviceK973533 Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF)Nidek, Inc. · 1997
- 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 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · 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) | K973533 | Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF) | Nidek, Inc. | 1997 | — |
| +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 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 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), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (37)
See all 372 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, 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 | — |
What is it indicated for?
Model 3-DX captures simultaneous stereo photographs of disc/fundus area on a single frame - suitable picture angle for stereoscopic optic disc glaucoma diagnosis.
Model 3-DXF has an additional fluorescence angiography capability to 3-DX.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973533: Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973533
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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