510(k) · Cleared
ClearedNoncon Robo Pachy F&a
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 Feb 22, 2008 as substantially equivalent to K980357 (Konan, Inc., 1998) after a 525-day review. Its family tree reaches back 2 generations to 1992. 10 later devices descend from it.
- Decided
- Feb 22, 2008
- Review
- 525 days
- Class
- Class II
- Product code
- NQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920906 (1992). 3 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- 1 generation backK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- This deviceK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK130565 Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK151706 Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK142417 SP-1PSpecular MicroscopeTopcon Corporation · 2015
- Descendant · cites it directly · 1 of its ownK081797 Image Storage System, Model KSS-400Konan Medical, Inc. · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K120264Konan Specular Microscope XivKonan Medical, Inc. · 2012 · cites it directly7descendants
- K130565Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · 2 generations on2descendants
- K151706Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · 2 generations on1descendant
- K142417SP-1PSpecular MicroscopeTopcon Corporation · 2015 · 2 generations on1descendant
- K081797Image Storage System, Model KSS-400Konan Medical, Inc. · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −1 | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| 0 (this device) | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| +1 | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| +2 | K130565 | Specular Microscope Cem-530 | Nidek Co., Ltd. | 2013 | 1 |
| +2 | K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016 | 2 |
| +2 | K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015 | — |
| +1 | K081797 | Image Storage System, Model KSS-400 | Konan Medical, Inc. | 2009 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterSummary page 1…ra and optical pachymeter Classification Name: Camera, Ophthalmic, AC-powered (3) Equivalent legally-marketed devices: Konan Noncon Robo Pachy, K980357 (4) Description The Noncon Robo Pachy K&A specular microscope and optical pachymeter is a non-contact ophthalmic micros… | 1998 |
| * | — | Konan Noncon Robo F&A Named without a submission number |
What descends from it? (10)
2 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 16 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120264 (Konan Medical, Inc., 2012) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K980357.
How does its category compare?
All NQE devicesNQE Microscope, Specular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062763: Noncon Robo Pachy F&a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062763
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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