510(k) · Cleared
ClearedKonan Specular Microscope Xiv
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 Apr 11, 2012 as substantially equivalent to K062763 (Konan Medical, Inc., 2008) after a 72-day review. Its family tree reaches back 3 generations to 1992. 7 later devices descend from it.
- Decided
- Apr 11, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- NQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920906 (1992). 4 ancestors in all. 7 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- 2 generations backK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- 1 generation backK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- This deviceK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK130565 Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK151706 Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK142417 SP-1PSpecular MicroscopeTopcon Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK253039 Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025
- Descendant · cites it directly · 0 of its ownK191558 Konan Specular Microscope XVIIKonan Medical, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130565Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · cites it directly2descendants
- K151706Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · cites it directly1descendant
- K142417SP-1PSpecular MicroscopeTopcon Corporation · 2015 · cites it directly1descendant
- K253039Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025 · 2 generations on0descendants
- K191558Konan Specular Microscope XVIIKonan Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −2 | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| −1 | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| 0 (this device) | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| +1 | K130565 | Specular Microscope Cem-530 | Nidek Co., Ltd. | 2013 | 1 |
| +1 | K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016 | 2 |
| +1 | K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015 | — |
| +2 | K253039 | Auto Kerato-Refracto Tonometer TRK-3 Omnia | Topcon Corporation | 2025 | — |
| +1 | K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K062763 | Noncon Robo Pachy F&aSummary page 1…OF PREDICATE DEVICE The predicate device is the Konan Medical, Inc. Noncon Robo Pachy F&A non-contact specular microscope, which was cleared by FDA under 5 10(k) number K062763 on February 22, 2008. 11.4 DEVICE DESCRIPTION The Konan Specular Microscope XIV, CelIChek Plus, is a non-contact ophthalmic… | 2008 |
What descends from it? (7)
6 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130565 (Nidek Co., Ltd., 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K062763.
How does its category compare?
All NQE devicesNQE Microscope, Specular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Specular Microscope XIV, Celehek Plus, is a non-contact ophthalmic.
microscope, optical pachymeter, and camera intended for examination of the comeal
endlotheliumn and for measurement of the thickness of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120264: Konan Specular Microscope Xiv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120264
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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