510(k) · Cleared
ClearedImpedimed - Bis Extra Cellular Fluid Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ImpediMed Limited · OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
Cleared on May 31, 2013 as substantially equivalent to K100811 (ImpediMed Limited, 2011) after a 109-day review. Its family tree reaches back 4 generations to 1991. 6 later devices descend from it.
- Decided
- May 31, 2013
- Review
- 109 days
- Class
- Class II
- Product code
- OBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904109 (1991). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- 3 generations backK052319 Impedimed - Body Composition Analyzer, Model Imp SFB7Impedimed Pty, Ltd. · 2006
- 2 generations backK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- 1 generation backK100811 Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited · 2011
- This deviceK130338 Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited · 2013
- Descendant · cites it directly · 2 of its ownK171186 Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017
- Descendant · cites it directly · 2 of its ownK172122 SOZOImpediMed Limited · 2017
- Descendant · 2 generations on · 1 of its ownK182967 Visor SystemCerebrotech Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK180126 SOZOImpediMed Limited · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK253840 STEDI Scan DeviceStroke DX · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171186Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017 · cites it directly2descendants
- K172122SOZOImpediMed Limited · 2017 · cites it directly2descendants
- K182967Visor SystemCerebrotech Medical Systems, Inc. · 2018 · 2 generations on1descendant
- K180126SOZOImpediMed Limited · 2018 · 2 generations on1descendant
- K253840STEDI Scan DeviceStroke DX · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | 1991 | — |
| −3 | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7 | Impedimed Pty, Ltd. | 2006 | — |
| −2 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| −1 | K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 | ImpediMed Limited | 2011 | — |
| 0 (this device) | K130338 | Impedimed - Bis Extra Cellular Fluid Analysis | ImpediMed Limited | 2013 | — |
| +1 | K171186 | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | 2017 | — |
| +1 | K172122 | SOZO | ImpediMed Limited | 2017 | — |
| +2 | K182967 | Visor System | Cerebrotech Medical Systems, Inc. | 2018 | — |
| +2 | K180126 | SOZO | ImpediMed Limited | 2018 | 1 |
| +3 | K253840 | STEDI Scan Device | Stroke DX | 2026 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400Summary page 1…Gastroenterology/Urology Device class: Class 11 Predicate Devices ImpediMed Limited, L-Det! U400 81$ Extra Cellular Fluid Analysis (K10081 1) Intended Use I Indications for Use The L-Dex® U400 is a bioinipedance spectroscopy device for use on adult hu 'man patients, ut… | 2011 |
What descends from it? (6)
2 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K171186 (Cerebrotech Medical Systems, 2017) has gone furthest, with 2 descendants of its own.
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. 2013, 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?
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men. The device is only indicated for patients who will have or who have had…
Read the full statement (131 words)
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.
The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated.
Lymphedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 device for uploading data on to the PC from the L-Dex U400, 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/K130338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130338: Impedimed - Bis Extra Cellular Fluid Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130338
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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