510(k) · Cleared
ClearedKonan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konan, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Apr 24, 1998 as substantially equivalent to K950091 (Konan Medical, Inc., 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1992. 11 later devices descend from it.
- Decided
- Apr 24, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920906 (1992). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- This deviceK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- Descendant · cites it directly · 10 of its ownK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK130565 Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK151706 Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK142417 SP-1PSpecular MicroscopeTopcon Corporation · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062763Noncon Robo Pachy F&aKonan Medical, Inc. · 2008 · cites it directly10descendants
- K120264Konan Specular Microscope XivKonan Medical, Inc. · 2012 · 2 generations on7descendants
- K130565Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · 3 generations on2descendants
- K151706Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · 3 generations on1descendant
- K142417SP-1PSpecular MicroscopeTopcon Corporation · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| 0 (this device) | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| +1 | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| +2 | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| +3 | K130565 | Specular Microscope Cem-530 | Nidek Co., Ltd. | 2013 | 1 |
| +3 | K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016 | 2 |
| +3 | K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.8 · 5 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 |
|---|---|---|---|
| * | K950091 | Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000Summary page 4…elial Microscope and Cafhera and optical pachymeter Classification Name: Camera, Ophthalmic, AC-powered (3) Equivalent legally-marketed devices: 1. Konan Noncon Robo, K950091 2. DGH 2000 ultrasonic pachymeter, K920906 (4) Description The Noncon Robo Pachy specular microscope and optical pachymeter is… | 1995 |
| * | K920906 | DGH-500 PachymeterSummary page 4…achymeter Classification Name: Camera, Ophthalmic, AC-powered (3) Equivalent legally-marketed devices: 1. Konan Noncon Robo, K950091 2. DGH 2000 ultrasonic pachymeter, K920906 (4) Description The Noncon Robo Pachy specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optica… | 1992 |
What descends from it? (11)
See all 112 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 HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Konan Noncon Robo Pachy is a specular microscope and
optical pachymeter, manufactured by Konan Inc. It is a non-contact ophthalmic microscope and camera intended for
examination of the corneal endothelium, with the additional
capability of measuring the corneal thickness by optical means.
Cell counting and analysis programs are included, and are
indicated when it is desired to analyze the images of the cell
distribution of the eye.
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/K980357 · printed Nov 3, 2026
Cite this page
510(k) Report. “K980357: Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K980357
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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