510(k) · Cleared
ClearedBC (Body Composition Software)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rjl Systems, Inc. · MNW Analyzer, Body Composition
Cleared on Aug 2, 2007 as substantially equivalent to K862383 (Rjl Systems, Inc., 1987) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Aug 2, 2007
- Review
- 115 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K830292 (1983). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- 1 generation backK050395 Impedimed - Body Composition AnalysisImpedimed Pty, Ltd. · 2005
- This deviceK070999 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 1 of 1 · See all- K103026Electro Sensor -Body CompositionLd Technology, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| −1 | K050395 | Impedimed - Body Composition Analysis | Impedimed Pty, Ltd. | 2005 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K862383 | Modified Model Bia-103 Body Composition AnalyzerSummary page 1…CFR 870.2770 Classification Name: Impedance Plethysmograph Product Code: MNW 2) Equivalent Legally Marketed Devices: RJL Systems; BIA-103 (K862383) Impedimed; DF50 ( K050395) BodyStat; QuadScan 4000 ( K002835 ) 3) Indications for use BC is a soft… | 1987 |
| * | K050395 | Impedimed - Body Composition AnalysisSummary page 1…n Name: Impedance Plethysmograph Product Code: MNW 2) Equivalent Legally Marketed Devices: RJL Systems; BIA-103 (K862383) Impedimed; DF50 ( K050395) BodyStat; QuadScan 4000 ( K002835 ) 3) Indications for use BC is a software accessory for RJL Systems Quan… | 2005 |
| * | K002835 | BodystatSummary page 1…oduct Code: MNW 2) Equivalent Legally Marketed Devices: RJL Systems; BIA-103 (K862383) Impedimed; DF50 ( K050395) BodyStat; QuadScan 4000 ( K002835 ) 3) Indications for use BC is a software accessory for RJL Systems Quantum-11, Quantum-X, Quantum Desktop, and… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103026 | Electro Sensor -Body Composition | 2011 | 0 |
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 24 years and passes through 2 companies; a new generation was cleared every 21.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103026 (Ld Technology, LLC, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
BC is a software accessory for RJL Systems Quantum-Il, Quantum-X, Quantum Desktop, and Quantum-Ill. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-Ill analyzers, the computer must have an available serial port. Indications for Use: Calculation and Historical Tracking of: * Actual Impedance * Actual Phase Angle (PA) * Estimated Body Fat (FAT) * Estimated…
Read the full statement (119 words)
BC is a software accessory for RJL Systems Quantum-Il, Quantum-X, Quantum Desktop, and Quantum-Ill. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-Ill analyzers, the computer must have an available serial port.
Indications for Use:
Calculation and Historical Tracking of:
* Actual Impedance
* Actual Phase Angle (PA)
* Estimated Body Fat (FAT)
* 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)
BC is intended only for use on normally healthy adults and adolescents age 9-94.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070999: BC (Body Composition Software).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070999
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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