510(k) · Cleared
ClearedCellChek 20 rc
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 Jun 15, 2021 as substantially equivalent to K081797 (Konan Medical, Inc., 2009) after a 224-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jun 15, 2021
- Review
- 224 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K905070 (1991). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 3 generations backK961637 Picker MR Workstations (Vistar,Montage and Oncall)Philips Medical Systems (Cleveland), Inc. · 1996
- 2 generations backK992354 SNT Image Analysis SystemSurgical Navigation Technologies, Inc. · 1999
- 1 generation backK081797 Image Storage System, Model KSS-400Konan Medical, Inc. · 2009
- This deviceK203244 CellChek 20 rcKonan Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −3 | K961637 | Picker MR Workstations (Vistar,Montage and Oncall) | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −2 | K992354 | SNT Image Analysis System | Surgical Navigation Technologies, Inc. | 1999 | — |
| −1 | K081797 | Image Storage System, Model KSS-400 | Konan Medical, Inc. | 2009 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K081797 | Image Storage System, Model KSS-400Summary page 4…Identification of Predicate Device The predicate device is the Image Storage System, Model KSS-400, which was cleared by FDA under 510(k) number K081797 on Jan 22, 2009. Konan Medical, Inc. Page 1… | 2009 |
| † | K191558 | Konan Specular Microscope XVII | 2020 |
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 30 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.
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/K203244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203244: CellChek 20 rc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203244
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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