510(k) · Cleared
ClearedElectro Sensor -Body Composition
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ld Technology, LLC · MNW Analyzer, Body Composition
Cleared on Mar 29, 2011 as substantially equivalent to K070999 (Rjl Systems, Inc., 2007) and 1 other predicate after a 168-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Mar 29, 2011
- Review
- 168 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K830292 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- 2 generations backK050395 Impedimed - Body Composition AnalysisImpedimed Pty, Ltd. · 2005
- 1 generation backK070999 BC (Body Composition Software)Rjl Systems, Inc. · 2007
- This deviceK103026 Electro Sensor -Body CompositionLd Technology, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| −2 | K050395 | Impedimed - Body Composition Analysis | Impedimed Pty, Ltd. | 2005 | — |
| −1 | K070999 | BC (Body Composition Software) | Rjl Systems, Inc. | 2007 | — |
| 0 (this device) | K103026 | Electro Sensor -Body Composition | Ld Technology, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K070999 | BC (Body Composition Software)Summary page 2…: 21 CFR 870.2770 Product Code: MNW Classification: Class 11 Classification Advisory: Cardiovascular 3. Predicate legally marketed devices BC body composition software, K070999 Applicant: RIL systems. Inc Product code MNW DF5O Body Composition Analysis K052395 Applicant: ImpediMed Limited. Product code: M… | 2007 |
| * | K050395 | Impedimed - Body Composition Analysis Our reading of the summary gave K052395, FDA’s number for Sterile Equipment Covers (Volcano Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DF50 Body Composition Analysis”. | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
Calculation and Historical Tracking of. * Actual Resistance * Actual Reactance * Actual Impedance * Actual Phase Angle (PA) * Estimated Body Fat Mass (FM) * Estimated Fat Free Mass (FFM) * Estimated Total Body Water (TBW) * Estimated Intra-Cellular Water (ICW) * Estimated Extra-Cellular Water (ECW) * Estimated Basal Metabolic Rate (BMR) * Estimated Daily Energy Expenditure (DEE) * Actual Body Mass Index (BMI) The device is not intended for use for…
Read the full statement (190 words)
Calculation and Historical Tracking of.
* Actual Resistance
* Actual Reactance
* Actual Impedance
* Actual Phase Angle (PA)
* Estimated Body Fat Mass (FM)
* Estimated Fat Free Mass (FFM)
* Estimated Total Body Water (TBW)
* Estimated Intra-Cellular Water (ICW)
* Estimated Extra-Cellular Water (ECW)
* Estimated Basal Metabolic Rate (BMR)
* Estimated Daily Energy Expenditure (DEE)
* Actual Body Mass Index (BMI)
The device is not intended for use for diagnosis.
The actual resistance, reactance, impedance and phase angle have no clinical utility and are for
calculation of body composition only.
The data are stored in PC in the Backup system of the E.S-BC software.
As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over
12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican
Americans in the US population.
As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years
old and under 63 years old and Caucasian and Hispanic Americans in the US population.
The device is for over-the-counter use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103026: Electro Sensor -Body Composition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103026
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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