510(k) · Cleared
ClearedKonan Specular Microscope XVII
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 26, 2020 as substantially equivalent to K120264 (Konan Medical, Inc., 2012) after a 288-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Mar 26, 2020
- Review
- 288 days
- Class
- Class II
- Product code
- NQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920906 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- 3 generations backK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- 2 generations backK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- 1 generation backK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- This deviceK191558 Konan Specular Microscope XVIIKonan Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −3 | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| −2 | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| −1 | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K120264 | Konan Specular Microscope XivSummary page 5…ic Identification of Predicate Device The predicate device is the Konan Specular Microscope XIV, CellChek Plus, which was cleared by FDA under 510(k) number K120264 on April 11, 2012. In addition, the company has utilized the NONCON ROBO PACHY F&A, K062763, as a reference d… | 2012 |
| † | K062763 | Noncon Robo Pachy F&a | 2008 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K120264.
How does its category compare?
All NQE devicesNQE Microscope, Specular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.
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/K191558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191558: Konan Specular Microscope XVII.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191558
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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