510(k) · Cleared
ClearedLymphaTech Mobile 3D Measuring Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lymphatech, Inc. · SFG Camera, Surgical, Measurement
Cleared on Jul 22, 2025 as substantially equivalent to K131596 (Woundvision, LLC, 2013) after a 90-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Jul 22, 2025
- Review
- 90 days
- Class
- Class I
- Product code
- SFG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070426 (2007). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 SFG? 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 |
|---|---|---|---|
| * | K131596 | Wound Measuring & Monitoring DeviceSummary page 5…Regulation: 21 CFR §878.4160 Regulatory Classification: Class 1 Product Code: SFG Predicate Device: Scout (K131596) Reference Device: decimal3D (K192554) Device Description The LymphaTech Mobile 3D Measuring Tool is a standalone software… | 2013 |
| † | K192554 | decimal3D | 2019 |
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 18 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K131596.
How does its category compare?
All SFG devicesSFG Camera, Surgical, Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFG
Too few SFG 510(k)s in any year since 2007 to give a median.
Recalls per year · SFG
No recall names SFG since 2007.
Adverse event reports per year · SFG
No MAUDE report names SFG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 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 | 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 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the…
Read the full statement (155 words)
The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the Structure Sensor camera to accurately capture and construct a 3D model of a patient’s anatomy. It is intended for trained and qualified healthcare professionals, who are trained in its use. The 3D Measuring Tool is to be used on a patient population that includes non-pregnant female or male adults. The 3D Measuring Tool is intended to be used in any environment where health care is provided by a qualified health care professional. The 3D Measuring Tool does not provide a diagnosis or therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251255 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251255: LymphaTech Mobile 3D Measuring Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251255
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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