510(k) · Cleared
ClearedDemetra BDEM-01 Dermatoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco N.V. · PSN Light Based Imaging
Cleared on Dec 13, 2019 as substantially equivalent to K040171 (Visiomed AG, 2004) after a 72-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 13, 2019
- Review
- 72 days
- Class
- Class II
- Product code
- PSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010259 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 2 generations backK032760 Apax Pacs SystemTis, Inc. · 2003
- 1 generation backK040171 Microderm, Model/Version 3.5Visiomed AG · 2004
- This deviceK192829 Demetra BDEM-01 DermatoscopeBarco N.V. · 2019
- Descendant · cites it directly · 0 of its ownK230448 DeepX DermoSight DermatoscopeDeepx Health, LLC · 2023
- Descendant · cites it directly · 0 of its ownK213957 Demetra Dermatoscope BDEM-01Barco N.V. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −2 | K032760 | Apax Pacs System | Tis, Inc. | 2003 | — |
| −1 | K040171 | Microderm, Model/Version 3.5 | Visiomed AG | 2004 | — |
| 0 (this device) | K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | 2019 | — |
| +1 | K230448 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | 2023 | — |
| +1 | K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 PSN? 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 PSN device
- #1 K230448 DeepX DermoSight Dermatoscopescore 6.3 · 4 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 |
|---|---|---|---|
| * | K040171 | Microderm, Model/Version 3.5Summary page 4…p Classification code: PSN Regulation number: 878.4580 5. Predicate Microderm - K040171 device The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize 6. Device… | 2004 |
What descends from it? (2)
2 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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230448 (Deepx Health, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040171.
How does its category compare?
All PSN devicesPSN Light Based Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PSN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PSN
Too few PSN 510(k)s in any year since 2007 to give a median.
Recalls per year · PSN
No recall names PSN since 2007.
Adverse event reports per year · PSN
No MAUDE report names PSN since 2007.
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 | 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 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and
white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved,
displayed and reviewed by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192829 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192829: Demetra BDEM-01 Dermatoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192829
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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