510(k) · Cleared
ClearedBC100 Body Composition Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Athletic Iq, Inc. · MNW Analyzer, Body Composition
Cleared on May 24, 2006 as substantially equivalent to K830292 (Rjl Systems, Inc., 1983) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 24, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011652 (2001). 3 ancestors in all, the oldest K830292 (1983). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011652 | Body Fat Analyzer, Model HBF-306 | Omron Healthcare, Inc. | 2001 | — |
| −1 | K030203 | Long Well LW-6DXX Series Body Fat Analyzer | Long Well Electronics Corp. | 2003 | — |
| 0 (this device) | K060552 | BC100 Body Composition Analysis System | Athletic Iq, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 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 |
|---|---|---|---|
| * | K830292 | Bioelectrical Impedance Analyzer #101Summary page 1…yzer Classification: Impedance plethysmograph (body composition analyzer) / MNW Predicate Devices RJL Quantum II Bioelectrical Body Composition Analyzer (K830292) Omron BodyLogic Body Fat Analyzer (KO1 1652) Long-Well 6DS Body Fat Analyzer (K0… | 1983 |
| * | K011652 | Body Fat Analyzer, Model HBF-306 | 2001 |
| * | K030203 | Long Well LW-6DXX Series Body Fat AnalyzerSummary page 1…ctrical Body Composition Analyzer (K830292) Omron BodyLogic Body Fat Analyzer (KO1 1652) Long-Well 6DS Body Fat Analyzer (K030203) Indications for Use: The BC1 00 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subj… | 2003 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K830292.
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?
The BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060552: BC100 Body Composition Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060552
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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