510(k) · Cleared
ClearedSilhouette, Model 1000.01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aranz Medical Limited · FXN Tape, Camera, Surgical
Cleared on Jun 29, 2007 after a 136-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jun 29, 2007
- Review
- 136 days
- Class
- Class I
- Product code
- FXN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK070426 Silhouette, Model 1000.01Aranz Medical Limited · 2007
- Descendant · cites it directly · 4 of its ownK131596 Wound Measuring & Monitoring DeviceWoundvision, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK251678 Swift Ray 1Swift Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251255 LymphaTech Mobile 3D Measuring ToolLymphatech, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK230734 Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager…Precision Healing, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK190074 Presero 3D Scanning SystemCertis Health · 2019
Most influential descendants
Showing 5 of 5 · See all- K131596Wound Measuring & Monitoring DeviceWoundvision, LLC · 2013 · cites it directly4descendants
- K251678Swift Ray 1Swift Medical, Inc. · 2026 · 2 generations on0descendants
- K251255LymphaTech Mobile 3D Measuring ToolLymphatech, Inc. · 2025 · 2 generations on0descendants
- K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC · 2023 · 2 generations on0descendants
- K190074Presero 3D Scanning SystemCertis Health · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070426 | Silhouette, Model 1000.01 | Aranz Medical Limited | 2007 | — |
| +1 | K131596 | Wound Measuring & Monitoring Device | Woundvision, LLC | 2013 | — |
| +2 | K251678 | Swift Ray 1 | Swift Medical, Inc. | 2026 | — |
| +2 | K251255 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | 2025 | — |
| +2 | K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI)… | Precision Healing, LLC | 2023 | — |
| +2 | K190074 | Presero 3D Scanning System | Certis Health | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 FXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Verge Videometer Named without a submission number | |
| * | — | Visitrak Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131596 | Wound Measuring & Monitoring Device | 2013 | 4 |
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, K131596 (Woundvision, LLC, 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FXN devicesFXN Tape, Camera, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FXN
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FXN
Too few FXN 510(k)s in any year since 2007 to give a median.
Recalls per year · FXN
No recall names FXN since 2007.
Adverse event reports per year · FXN
No MAUDE report names FXN 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070426: Silhouette, Model 1000.01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070426
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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