510(k) · Cleared
ClearedImpedimed - Body Composition Analysis
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 Jul 13, 2005 as substantially equivalent to K830292 (Rjl Systems, Inc., 1983) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Jul 13, 2005
- Review
- 147 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830292 (1983). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- This deviceK050395 Impedimed - Body Composition AnalysisImpedimed Pty, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK070999 BC (Body Composition Software)Rjl Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK103026 Electro Sensor -Body CompositionLd Technology, LLC · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| 0 (this device) | K050395 | Impedimed - Body Composition Analysis | Impedimed Pty, Ltd. | 2005 | — |
| +1 | K070999 | BC (Body Composition Software) | Rjl Systems, Inc. | 2007 | — |
| +1 | K103026 | Electro Sensor -Body Composition | Ld Technology, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K830292 | Bioelectrical Impedance Analyzer #101Summary page 2…pany: RJL Systems, Inc Device name: BIOELECTRICAL IMPEDANCE ANALYZER #101 510 (K) number: K 830292 Product code: DSB 2. Company BODYSTAT LTD Device name: BODYSTAT 1500MD… | 1983 |
| * | K994242 | Bodystat 1500MDD Body Composition Monitoring UnitSummary page 2…BODYSTAT LTD Device name: BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT 510 (K) number: K 994242 Product code: MNW 000020 Letterhead Summary do… | 2000 |
What descends from it? (2)
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?
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?
A body composition analyzer and a software package that will estimate, display and store the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICW), Extra cellular Water (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are…
Read the full statement (131 words)
A body composition analyzer and a software package that will estimate, display and store the following body composition parameters:
Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICW), Extra cellular Water (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR).
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 users height, weight, age, % ideal weight, time and date of measurement, Practitioner's name and Device serial number.
This device is intended for use on healthy children (9 - 16 years old), general and obese adult subjects, only for body composition assessment in the home or clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050395: Impedimed - Body Composition Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050395
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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