510(k) · Cleared
ClearedAnterior Eye-Segment Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · MXK Device, Analysis, Anterior Segment
Cleared on Aug 6, 1999 as substantially equivalent to K973533 (Nidek, Inc., 1997) and 1 other predicate after a 113-day review. Its family tree reaches back 1 generation to 1996. 33 later devices descend from it.
- Decided
- Aug 6, 1999
- Review
- 113 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955442 (1996). 2 ancestors in all. 33 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- This deviceK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- Descendant · cites it directly · 18 of its ownK030719 Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003 · Recalled
- Descendant · cites it directly · 18 of its ownK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- Descendant · 2 generations on · 16 of its ownK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- Descendant · 3 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- Descendant · 4 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K030719Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003 · cites it directly18descendants
- K012873Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001 · cites it directly18descendants
- K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003 · 2 generations on16descendants
- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 3 generations on14descendants
- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| 0 (this device) | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| +1 | K030719 | Pentacam Scheimpflug Camera | Oculus Optikgerate GmbH | 2003 | 1 |
| +1 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| +2 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| +3 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| +4 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 MXK? 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 MXK device
- #1 K251848 Pentacam® Cornea OCTscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K973533 | Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF)Summary page 1…S-1000 Anterior Eye-Segment Analysis System is claimed to be substantially equivalent to the following currently Marketed Devices: e Nidek, 3-DXF Stereo Fundus Camera - K973533 — received 11/4/ 97 ¢ KOWA Optimed Inc., SC-1200 Slit Lamp — K955442 — received 1/3/96 PRODUCT DESCRIPTION This DEVICE is a non… | 1997 |
| * | K955442 | Kowa SC-1200 Photo Slit Lamp SystemSummary page 1…ially equivalent to the following currently Marketed Devices: e Nidek, 3-DXF Stereo Fundus Camera - K973533 — received 11/4/ 97 ¢ KOWA Optimed Inc., SC-1200 Slit Lamp — K955442 — received 1/3/96 PRODUCT DESCRIPTION This DEVICE is a non-invasive, table mounted, AC powered diagnostic sytem intended to tak… | 1996 |
What descends from it? (33)
See all 332 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?
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXK
Too few MXK 510(k)s in any year since 2007 to give a median.
Recalls per year · MXK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXK
1in 2025
MAUDE reports naming product code MXK, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EAS-1000 “Anterior Eye-Segment Analysis System” is intended to take photographs of the eye and surrounding area, for non-invasive illumination, magnification, observation, analysis and photography of the anterior segments of the eye, which include the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate and analyze conditions of lens (opaque crystalline lens), lens position (pre and post Intraocular Lens Transplant), anterior or posterior cortical opacity, cataracts (nuclear, subcapsular and or cortical) using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991284: Anterior Eye-Segment Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991284
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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