510(k) · Cleared
ClearedImpedimed - Body Composition Analyzer, Model Imp SFB7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impedimed Pty, Ltd. · MNW Analyzer, Body Composition
Cleared on Apr 4, 2006 as substantially equivalent to K904109 (Xitron Technologies, Inc., 1991) after a 222-day review. Its family tree reaches back 1 generation to 1991. 13 later devices descend from it.
- Decided
- Apr 4, 2006
- Review
- 222 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904109 (1991). 13 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- This deviceK052319 Impedimed - Body Composition Analyzer, Model Imp SFB7Impedimed Pty, Ltd. · 2006
- 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 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · 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) | 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 | — |
| +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 | — |
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 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 MNW? 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 MNW device
- #1 K231116 Multi-parameter detectorscore 11.4 · 14 generations · no Class I recall
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 |
|---|---|---|---|
| * | K904109 | Bio-Impedance AnalyzerSummary page 2…Xitron Technologies, Inc Device name: Bio-Impedlance Analyzer 510 (K) number: K 904109 Product code: DSB Classification panel: Cardiovascular Device cl… | 1991 |
What descends from it? (13)
See all 132 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?
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNW
110in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNW
No recall names MNW since 2007.
Adverse event reports per year · MNW
3in 2024
MAUDE reports naming product code MNW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 109 | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 137 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 11 | 168 | 0 | 0 |
| 2012 | 4 | 103 | 0 | 0 |
| 2013 | 9 | 144 | 0 | 0 |
| 2014 | 3 | 110 | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
(1) Imp SFB7 - A bioelectrical impedance analyzer/monitor that is intended to estimate the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), and Body Mass Index (BMI). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body…
Read the full statement (255 words)
(1) Imp SFB7 - A bioelectrical impedance analyzer/monitor that is intended to estimate the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), and Body Mass Index (BMI). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole-Cole plot, resistance vs. frequency plot, reactance vs. frequency plot, subject height, weight, age and sex.
(2) BioImp Body Composition Analyzer PC Software: A PC software package that is intended to be used only with the ImpediMed Imp SFB7 Analyzer for uploading the MFBIA mode data on to the PC from Imp SFB7 via an Ethernet port for storing, processing and analysing of MFBIA bioimpedance measurements. This displays Cole-Cole plot, body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), Body Mass Index (BMI), and subject height, weight, age, sex, time, and date of measurement, Practitioner's name and Device serial number, and bioelectrical parameters resistance (R), reactance (Xc), and impedance (Z) and phase angle (Phi) at different frequencies (Between 4 kHz to 1000 kHz). The software can be used to generate patient body composition report displaying all the parameters stated above.
These devices are intended to be used only on healthy patients, who wish to have their body composition estimated in the home or clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052319: Impedimed - Body Composition Analyzer, Model Imp SFB7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052319
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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