510(k) · Cleared
ClearedDendrite Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dendrite Imaging, Inc. · QDG Parathyroid Autofluorescence Imaging Device
Cleared on Nov 28, 2025 as substantially equivalent to K190891 (Fluoptics, 2019) after a 60-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Nov 28, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- QDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190891 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK190891 Fluobeam LXFluoptics · 2019
- This deviceK253303 Dendrite Imaging SystemDendrite Imaging, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190891 | Fluobeam LX | Fluoptics | 2019 | — |
| 0 (this device) | K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | 2025 | — |
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 QDG? 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 QDG device
- #1 K233564 FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM®…score 9.8 · 2 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 |
|---|---|---|---|
| * | K190891 | Fluobeam LXSummary page 5…e Classification Name: Parathyroid Autofluorescence Imaging Device Regulation Number: 878.4550 Product Code(s): QDG Legally Marketed Predicate Devices: Predicate #: K190891 Predicate Trade Name (Primary Predicate is listed first): Fluobeam LX Product Code(s): QDG Device Description Summary: The D… | 2019 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K190891.
How does its category compare?
All QDG devicesQDG Parathyroid Autofluorescence Imaging Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QDG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QDG
Too few QDG 510(k)s in any year since 2007 to give a median.
Recalls per year · QDG
No recall names QDG since 2007.
Adverse event reports per year · QDG
No MAUDE report names QDG since 2007.
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 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dendrite Imaging System is indicated for use in real-time capturing and viewing of autofluorescent images of nerves and can be used as an adjunctive method to assist in the location of nerves during surgery. Use of the device is intended to assist, not replace, experienced visual assessment. The system is not to be used to confirm the absence of nerve tissue and is only to be used to assist in locating visually identified nerves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253303: Dendrite Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253303
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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