510(k) · Cleared
ClearedMicroderm, Model/Version 3.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visiomed AG · PSN Light Based Imaging
Cleared on Jun 8, 2004 as substantially equivalent to K032760 (Tis, Inc., 2003) after a 134-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Jun 8, 2004
- Review
- 134 days
- Class
- Class II
- Product code
- PSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010259 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 1 generation backK032760 Apax Pacs SystemTis, Inc. · 2003
- This deviceK040171 Microderm, Model/Version 3.5Visiomed AG · 2004
- Descendant · cites it directly · 2 of its ownK192829 Demetra BDEM-01 DermatoscopeBarco N.V. · 2019
- Descendant · cites it directly · 0 of its ownK230448 DeepX DermoSight DermatoscopeDeepx Health, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK213957 Demetra Dermatoscope BDEM-01Barco N.V. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −1 | K032760 | Apax Pacs System | Tis, Inc. | 2003 | — |
| 0 (this device) | K040171 | Microderm, Model/Version 3.5 | Visiomed AG | 2004 | — |
| +1 | K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | 2019 | — |
| +1 | K230448 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | 2023 | — |
| +2 | K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 6.2 · 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 |
|---|---|---|---|
| * | K032760 | Apax Pacs SystemSummary page 4…Phone: + 49 (234) 9787 76 Fax: + 49 (234) 9787 75 Contact: Thomas Schnepple 510(k) Numbers and Product Codes of equivalent devices. Apax Pacs System ’ 510(k) Number: #K032760 Praduct Code: LLZ CFR Section: 892.2050 Tis, Inc., Seoul Korea Indications for Use and Intended Population MicroDERM® is intend… | 2003 |
What descends from it? (3)
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 3 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192829 (Barco N.V., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K032760.
How does its category compare?
All PSN devicesPSN Light Based Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.,
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/K040171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040171: Microderm, Model/Version 3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040171
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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