510(k) · Cleared
ClearedMoisturemeterD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delfin Technologies, Ltd. · OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
Cleared on Nov 19, 2015 as substantially equivalent to K080825 (Impedimed Pty, Ltd., 2008) after a 366-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Nov 19, 2015
- Review
- 366 days
- Class
- Class II
- Product code
- OBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904109 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- 2 generations backK052319 Impedimed - Body Composition Analyzer, Model Imp SFB7Impedimed Pty, Ltd. · 2006
- 1 generation backK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- This deviceK143310 MoisturemeterDDelfin Technologies, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK220557 MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220557MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | 1991 | — |
| −2 | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7 | Impedimed Pty, Ltd. | 2006 | — |
| −1 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| 0 (this device) | K143310 | MoisturemeterD | Delfin Technologies, Ltd. | 2015 | — |
| +1 | K220557 | MoistureMeterD Compact, LymphScanner | Delfin Technologies, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 OBH? 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 OBH device
- #1 K253224 MySOZO Software version 6.0.1.2 (SW version…score 13.5 · 10 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 |
|---|---|---|---|
| * | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Summary page 4…BH Panel: Cardiovascular Device Class: Class 11 Predicate device: Company: ImpediMed Limited Trade Name: L-Dex U400 BIS Extra Cellular Fluid Analysis 510(k) Number: K080825 Classification name: Impedance Plethysmograph Regulation number: 870.2770 Product code: OBH Classification panel: Cardiovascu… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220557 | MoistureMeterD Compact, LymphScanner | 2022 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K220557 (Delfin Technologies, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080825.
How does its category compare?
All OBH devicesOBH Monitor, Extracellular Fluid, Lymphedema, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OBH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OBH
Too few OBH 510(k)s in any year since 2007 to give a median.
Recalls per year · OBH
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBH
No MAUDE report names OBH 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 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
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/K143310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143310: MoisturemeterD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143310
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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