510(k) · Cleared
ClearedStayhealthy Body Composition Analyzer, Models BC1 and BC2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stayhealthy, Inc. · MNW Analyzer, Body Composition
Cleared on Dec 13, 2005 as substantially equivalent to K011652 (Omron Healthcare, Inc., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Dec 13, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011652 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011652 Body Fat Analyzer, Model HBF-306Omron Healthcare, Inc. · 2001
- This deviceK052522 Stayhealthy Body Composition Analyzer, Models BC1 and BC2Stayhealthy, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011652 | Body Fat Analyzer, Model HBF-306 | Omron Healthcare, Inc. | 2001 | — |
| 0 (this device) | K052522 | Stayhealthy Body Composition Analyzer, Models BC1 and BC2 | Stayhealthy, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K011652 | Body Fat Analyzer, Model HBF-306Summary page 2…BC1 and BC2 are used to track the number of calories used by the client. (Based on selected motion detection). Predicate device(s); Omron Body Fat Analyzer Model HBF-306 K011652 Scientific Concepts and Si nificant Performance Characteristics Body fat analyzer Body c… | 2001 |
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?
- Its one ancestor has no recall.
- 11 other devices also cite its predicate K011652.
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 Stayhealthy BC I and the Stayhealthy/Fitness Expert BC2 devices are used solely to estimate the body fat and lean muscle components of the body using bioelectrical impedance technology. The Stayhealthy Calorie tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2) are companion devices and are used solely to determine the calories used by a client when worn for a given period of time. The BC t and BC2 can output, via computer driven…
Read the full statement (152 words)
The Stayhealthy BC I and the Stayhealthy/Fitness Expert BC2 devices are used solely to estimate the body fat and lean muscle components of the body using bioelectrical impedance technology.
The Stayhealthy Calorie tracker (CT1) and the Stayhealthy/Fitness Expert Calorie Tracker (CT2) are companion devices and are used solely to determine the calories used by a client when worn for a given period of time.
The BC t and BC2 can output, via computer driven software the percent body fat of a person. The lean body mass can also be displayed. The devices are intended for use by both men and women who are 18 and older. The CT I and the CT2 the companion devices can output, via computer driven software the number calories used by a person. The calories used can also be displayed. The BC1, BC2, CT1 and CT2 are not intended to be used to diagnose any known disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052522: Stayhealthy Body Composition Analyzer, Models BC1 and BC2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052522
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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