510(k) · Cleared
ClearedKonan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konan Medical, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Mar 1, 1995 after a 50-day review. The FDA summary names no predicate by number. 13 later devices descend from it.
- Decided
- Mar 1, 1995
- Review
- 50 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK950091 Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000Konan Medical, Inc. · 1995
- Descendant · cites it directly · 11 of its ownK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- Descendant · 2 generations on · 10 of its ownK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- Descendant · 3 generations on · 7 of its ownK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- Descendant · 4 generations on · 2 of its ownK130565 Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK151706 Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K980357Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998 · cites it directly11descendants
- K062763Noncon Robo Pachy F&aKonan Medical, Inc. · 2008 · 2 generations on10descendants
- K120264Konan Specular Microscope XivKonan Medical, Inc. · 2012 · 3 generations on7descendants
- K130565Specular Microscope Cem-530Nidek Co., Ltd. · 2013 · 4 generations on2descendants
- K151706Specular Microscope CEM- 530Nidek Co., Ltd. · 2016 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950091 | Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000 | Konan Medical, Inc. | 1995 | — |
| +1 | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| +2 | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| +3 | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| +4 | K130565 | Specular Microscope Cem-530 | Nidek Co., Ltd. | 2013 | 1 |
| +4 | K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 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 12.7 · 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?
The FDA summary names no predicate by number.
What descends from it? (13)
See all 132 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?
- Of its descendants, K980357 (Konan, Inc., 1998) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K950091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950091: Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950091
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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