510(k) · Cleared
ClearedImage Storage System, Model KSS-400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konan Medical, Inc. · NFJ System, Image Management, Ophthalmic
Cleared on Jan 22, 2009 as substantially equivalent to K980357 (Konan, Inc., 1998) and 2 other predicates after a 211-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Jan 22, 2009
- Review
- 211 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K905070 (1991). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 2 generations backK961637 Picker MR Workstations (Vistar,Montage and Oncall)Philips Medical Systems (Cleveland), Inc. · 1996
- 1 generation backK992354 SNT Image Analysis SystemSurgical Navigation Technologies, Inc. · 1999
- This deviceK081797 Image Storage System, Model KSS-400Konan Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK203244 CellChek 20 rcKonan Medical, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K203244CellChek 20 rcKonan Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −2 | K961637 | Picker MR Workstations (Vistar,Montage and Oncall) | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −1 | K992354 | SNT Image Analysis System | Surgical Navigation Technologies, Inc. | 1999 | — |
| 0 (this device) | K081797 | Image Storage System, Model KSS-400 | Konan Medical, Inc. | 2009 | — |
| +1 | K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 NFJ? 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 NFJ device
- #1 K260694 Zeiss Clinic 360score 15.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…alysis of specular microscope images Classification Name System, Image management, Ophthalmic (3) Equivalent legally-marketed devices Konan Noncon Robo Pachy, K980357 SNT Image Processing System, K992354 Konan Noncon Robo F&A Specular Microscope, K062763 KSS-400… | 1998 |
| * | K992354 | SNT Image Analysis SystemSummary page 1…ication Name System, Image management, Ophthalmic (3) Equivalent legally-marketed devices Konan Noncon Robo Pachy, K980357 SNT Image Processing System, K992354 Konan Noncon Robo F&A Specular Microscope, K062763 KSS-400… | 1999 |
| * | K062763 | Noncon Robo Pachy F&aSummary page 1…ivalent legally-marketed devices Konan Noncon Robo Pachy, K980357 SNT Image Processing System, K992354 Konan Noncon Robo F&A Specular Microscope, K062763 KSS-400 Page 5-4 (4) Descrip… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203244 | CellChek 20 rc | 2021 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K203244 (Konan Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K980357.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NFJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NFJ
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFJ
2in 2022
MAUDE reports naming product code NFJ, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 67 | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 73 | 0 | 6 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 87 | 1 | 2 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 5 | 175 | 0 | 4 |
| 2018 | 7 | 84 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 5 | 116 | 2 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 284 | 1 | 2 |
| 2023 | 4 | 85 | 0 | 0 |
| 2024 | 2 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081797: Image Storage System, Model KSS-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081797
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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