510(k) · Cleared
ClearedKerato Analyzer (Eka)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konan Medical, Inc. · NQE Microscope, Specular
Cleared on Mar 19, 2004 as substantially equivalent to K950091 (Konan Medical, Inc., 1995) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 19, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- NQE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950091 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK950091 Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000Konan Medical, Inc. · 1995
- This deviceK040373 Kerato Analyzer (Eka)Konan Medical, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950091 | Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000 | Konan Medical, Inc. | 1995 | — |
| 0 (this device) | K040373 | Kerato Analyzer (Eka) | Konan Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 NQE? 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 NQE device
- #1 K191558 Konan Specular Microscope XVIIscore -0.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K950091 | Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000Summary page 1…Name: Specular Microscope for Eye Banks. Classification Name: Camera, Ophthalmic, AC-powered (3) Equivalent legally-marketed devices: Konan Noncon Robo, K950091 Hai Labs EB2000 xyz, K994340 (4) Description The Konan Kerato Analyzer ("EKA") is a specular microscope used to… | 1995 |
| * | K994340 | Clinical Specular Microscope, Model Hai CL-1000XYZSummary page 1…ks. Classification Name: Camera, Ophthalmic, AC-powered (3) Equivalent legally-marketed devices: Konan Noncon Robo, K950091 Hai Labs EB2000 xyz, K994340 (4) Description The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of preserved cornea… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K950091.
How does its category compare?
All NQE devicesNQE Microscope, Specular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQE
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NQE
Too few NQE 510(k)s in any year since 2007 to give a median.
Recalls per year · NQE
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQE
No MAUDE report names NQE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts
of preserved corneas in eye banks and to measure the thicknesses of the corneas without
removing the corneas from their storage vials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040373: Kerato Analyzer (Eka).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040373
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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