510(k) · Cleared
ClearedWound Measuring & Monitoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Woundvision, LLC · FXN Tape, Camera, Surgical
Cleared on Dec 11, 2013 as substantially equivalent to K070426 (Aranz Medical Limited, 2007) after a 191-day review. Its family tree reaches back 1 generation to 2007. 4 later devices descend from it.
- Decided
- Dec 11, 2013
- Review
- 191 days
- Class
- Class I
- Product code
- FXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070426 (2007). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK070426 Silhouette, Model 1000.01Aranz Medical Limited · 2007
- This deviceK131596 Wound Measuring & Monitoring DeviceWoundvision, LLC · 2013
- Descendant · cites it directly · 0 of its ownK251678 Swift Ray 1Swift Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251255 LymphaTech Mobile 3D Measuring ToolLymphatech, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK230734 Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager…Precision Healing, LLC · 2023
- Descendant · cites it directly · 0 of its ownK190074 Presero 3D Scanning SystemCertis Health · 2019
Most influential descendants
Showing 4 of 4 · See all- K251678Swift Ray 1Swift Medical, Inc. · 2026 · cites it directly0descendants
- K251255LymphaTech Mobile 3D Measuring ToolLymphatech, Inc. · 2025 · cites it directly0descendants
- K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC · 2023 · cites it directly0descendants
- K190074Presero 3D Scanning SystemCertis Health · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070426 | Silhouette, Model 1000.01 | Aranz Medical Limited | 2007 | — |
| 0 (this device) | K131596 | Wound Measuring & Monitoring Device | Woundvision, LLC | 2013 | — |
| +1 | K251678 | Swift Ray 1 | Swift Medical, Inc. | 2026 | — |
| +1 | K251255 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | 2025 | — |
| +1 | K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI)… | Precision Healing, LLC | 2023 | — |
| +1 | K190074 | Presero 3D Scanning System | Certis Health | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K070426 | Silhouette, Model 1000.01Summary page 1…Regulatory Class: Class I ___________________Product Code: FXN 3. Marketed Device(s) to Aranz Medical, Silhouette, K070426 Which Equivalency is Claimed: 4. Device Description: The Scout isa combination digital camera and long-wave i… | 2007 |
What descends from it? (4)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K251678 (Swift Medical, Inc., 2026) has gone furthest, with 0 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. 2013, 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?
The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with…
Read the full statement (196 words)
The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data.
Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device.
The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional.
The Scout does not provide a diagnosis or therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131596: Wound Measuring & Monitoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131596
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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