510(k) · Cleared
ClearedSurgical Microscope (OMS2360, OMS2380)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zumax Medical Co., Ltd. · NBL Light-Induced Fluorescence Caries Detector
Cleared on Apr 28, 2026 as substantially equivalent to K171007 (Carl Zeiss Suzhou Co., Ltd., 2018) after a 265-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Apr 28, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN990002 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backDEN990002 Kavo DiagnodentKavo America · 2000
- 4 generations backK040063 Inspektor ProInspektor Dental Care BV · 2004
- 3 generations backK090169 Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc. · 2009
- 2 generations backK150672 VistaCam iX ProofDurr Dental AG · 2016
- 1 generation backK171007 Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018
- This deviceK252464 Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN990002 | Kavo Diagnodent | Kavo America | 2000 | — |
| −4 | K040063 | Inspektor Pro | Inspektor Dental Care BV | 2004 | — |
| −3 | K090169 | Spectra Fluorescence Caries Detection Device | Air Techniques, Inc. | 2009 | — |
| −2 | K150672 | VistaCam iX Proof | Durr Dental AG | 2016 | — |
| −1 | K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 2018 | — |
| 0 (this device) | K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | 2026 | — |
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 NBL? 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 NBL device
- #1 K242103 TRIOS Ready Tipscore 10.3 · 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? (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 |
|---|---|---|---|
| * | K171007 | Fluorescence ModeSummary page 6…I Regulation number: 21 CFR 872.1745 Review Panel: Dental Product code: NBL IV, Predicative Device 510(k): K171007 Device name: Fluorescence Mode Manufacturer: Carl Zeiss Suzhou Co., Ltd V, Device Description… | 2018 |
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 6 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All NBL devicesNBL Light-Induced Fluorescence Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NBL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBL
Too few NBL 510(k)s in any year since 2007 to give a median.
Recalls per year · NBL
No recall names NBL since 2007.
Adverse event reports per year · NBL
1in 2020
MAUDE reports naming product code NBL, 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 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light reflections and enhances contrast between red tissue and blood. The fluorescence mode is intended for use by qualified dental professionals in hospital clinical settings as an adjunctive aid to assist in the detection of dental caries.
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/K252464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252464: Surgical Microscope (OMS2360, OMS2380).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252464
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026