510(k) · Cleared
ClearedFluobeam LX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fluoptics · QDG Parathyroid Autofluorescence Imaging Device
Cleared on Jul 31, 2019 after a 117-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 31, 2019
- Review
- 117 days
- Class
- Class II
- Product code
- QDG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK190891 Fluobeam LXFluoptics · 2019
- Descendant · cites it directly · 2 of its ownK230898 FLUOBEAM® LX RedFluoptics Sas · 2023
- Descendant · cites it directly · 1 of its ownK233564 FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System…Fluoptics Sas (A Getinge Group Company) · 2023
- Descendant · cites it directly · 0 of its ownK253303 Dendrite Imaging SystemDendrite Imaging, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250455 FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company} · 2025
Most influential descendants
Showing 4 of 4 · See all- K230898FLUOBEAM® LX RedFluoptics Sas · 2023 · cites it directly2descendants
- K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company) · 2023 · cites it directly1descendant
- K253303Dendrite Imaging SystemDendrite Imaging, Inc. · 2025 · cites it directly0descendants
- K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company} · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190891 | Fluobeam LX | Fluoptics | 2019 | — |
| +1 | K230898 | FLUOBEAM® LX Red | Fluoptics Sas | 2023 | — |
| +1 | K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics Sas (A Getinge Group Company) | 2023 | — |
| +1 | K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | 2025 | — |
| +2 | K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics Sas (A Getinge Group Company} | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 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 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 K253303 Dendrite Imaging Systemscore 10.4 · 1 generation · 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 |
|---|---|---|---|
| * | — | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K230898 (Fluoptics Sas, 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QDG devicesQDG Parathyroid Autofluorescence Imaging Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Fluobeam® LX is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluobeam® LX is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ…
Read the full statement (162 words)
Fluobeam® LX is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluobeam® LX is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.
The Fluobeam® LX can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.
Use of the Fluobeam® LX device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190891: Fluobeam LX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190891
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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