510(k) · Cleared
ClearedBlueCheck™ Caries Detection & Monitoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incisive Technologies Pty, Ltd. · LFC Device, Caries Detection
Cleared on May 16, 2023 as substantially equivalent to K200601 (GreenMark Biomedical, Inc., 2021) after a 265-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- May 16, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- LFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964430 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LFC? 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 LFC device
- #1 K200601 LumiCare Caries Diagnostic Rinsescore 4.1 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K200601 | LumiCare Caries Diagnostic RinseSummary page 4…ENT and Dental Devices) Reviewing Division Division of Health Technology 1B (Dental and ENT Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device: K200601, LumiCare™ Caries Detection Rinse, GreenMark Biomedical, Inc. Reference Device: K955445, Caries Finder, Danville Engineering, In… | 2021 |
| † | K955445 | Caries Finder | 1996 |
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 26 years and passes through 3 companies; a new generation was cleared every 24.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LFC devicesLFC Device, Caries Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LFC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFC
Too few LFC 510(k)s in any year since 2007 to give a median.
Recalls per year · LFC
No recall names LFC since 2007.
Adverse event reports per year · LFC
1in 2009
MAUDE reports naming product code LFC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To aid the dental professional in the visualization of carious lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222560: BlueCheck™ Caries Detection & Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222560
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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