510(k) · Cleared

Cleared

Demetra Dermatoscope BDEM-01

K213957510(k) SpecialCleared Mar 11, 202284-day reviewClass II21 CFR 878.4580

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Barco N.V. · PSN Light Based Imaging

Cleared on Mar 11, 2022 as substantially equivalent to K192829 (Barco N.V., 2019) after an 84-day review. Its family tree reaches back 4 generations to 2001.

Decided: Mar 11, 2022
Review: 84 days
Class: Class II
Product code: PSN
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K010259 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
3 generations backK032760 Apax Pacs SystemTis, Inc. · 2003
2 generations backK040171 Microderm, Model/Version 3.5Visiomed AG · 2004
1 generation backK192829 Demetra BDEM-01 DermatoscopeBarco N.V. · 2019
This deviceK213957 Demetra Dermatoscope BDEM-01Barco N.V. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K010259	Mediface Pacs	Mediface Co., Ltd.	2001	—
−3	K032760	Apax Pacs System	Tis, Inc.	2003	—
−2	K040171	Microderm, Model/Version 3.5	Visiomed AG	2004	—
−1	K192829	Demetra BDEM-01 Dermatoscope	Barco N.V.	2019	—
0 (this device)	K213957	Demetra Dermatoscope BDEM-01	Barco N.V.	2022	—

FIG. 1 — Lineage of K213957, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 6.2 · 4 generations · no Class I recall
#2 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K192829	Demetra BDEM-01 Dermatoscope Summary page 4 …Classification code: PSN Regulation number: 878.4580 5. Predicate Demetra BDEM-01 – K192829 device The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize 6. Device…	Barco N.V.	2019	—
†	K201408	Demetra Analytics Toolkit	Barco N.V.	2021	—

Also cleared against K192829: 1 other device →

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 21 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K192829.

How does its category compare?

All PSN devices

PSN Light Based Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · PSN

1in 2023

2007high 1 (2007) · low 0 (2009)2026

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	MAUDE reports
2007	1	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	1	—	0
2020	0	—	0
2021	1	—	0
2022	1	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K213957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K213957: Demetra Dermatoscope BDEM-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213957

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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