510(k) · Decided
DecidedImpedimed-Extracellular Fluid Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impedimed Pty, Ltd. · OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
Cleared on Mar 30, 2007 as substantially equivalent to K904109 (Xitron Technologies, Inc., 1991) and 1 other predicate after a 770-day review. Its family tree reaches back 1 generation to 1991. 11 later devices descend from it.
- Decided
- Mar 30, 2007
- Review
- 770 days
- Class
- Class II
- Product code
- OBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904109 (1991). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- This deviceK050415 Impedimed-Extracellular Fluid AnalysisImpedimed Pty, Ltd. · 2007
- Descendant · cites it directly · 10 of its ownK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- Descendant · 2 generations on · 7 of its ownK100811 Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited · 2011
- Descendant · 3 generations on · 6 of its ownK130338 Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited · 2013
- Descendant · 4 generations on · 2 of its ownK171186 Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017
- Descendant · 4 generations on · 2 of its ownK172122 SOZOImpediMed Limited · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080825Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008 · cites it directly10descendants
- K100811Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited · 2011 · 2 generations on7descendants
- K130338Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited · 2013 · 3 generations on6descendants
- K171186Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017 · 4 generations on2descendants
- K172122SOZOImpediMed Limited · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | 1991 | — |
| 0 (this device) | K050415 | Impedimed-Extracellular Fluid Analysis | Impedimed Pty, Ltd. | 2007 | — |
| +1 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| +2 | K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 | ImpediMed Limited | 2011 | — |
| +3 | K130338 | Impedimed - Bis Extra Cellular Fluid Analysis | ImpediMed Limited | 2013 | — |
| +4 | K171186 | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | 2017 | — |
| +4 | K172122 | SOZO | ImpediMed Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K904109 | Bio-Impedance AnalyzerSummary page 2…fl@flfll N/ ABN 65 089 705 144 Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496 Email: [email protected] Xitron Technologies, Inc Bio-Impedance Analyzer K 904109 DSB Cardiovascular Class Il Bodystat Ltd Bodystat Quad Scan 4000 K 002835 MNW Cardiovascular Class-ll page2 of 5 UUKJOS… | 1991 |
| * | K002835 | BodystatSummary page 2…3423 1496 Email: [email protected] Xitron Technologies, Inc Bio-Impedance Analyzer K 904109 DSB Cardiovascular Class Il Bodystat Ltd Bodystat Quad Scan 4000 K 002835 MNW Cardiovascular Class-ll page2 of 5 UUKJOS " Ifll,gfl'lflfll N/, ImpediMed Ltd ABN 65 089 705 144 Building 4B… | 2001 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | 2008 | 10 |
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?
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. 2007, 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?
Imp XCA - A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.
Lymphoedema Analysis PC Software — an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.
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/K050415 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050415: Impedimed-Extracellular Fluid Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050415
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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