510(k) · Cleared
ClearedBody Composition Monitor with Scale, Model HBF-500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · MNW Analyzer, Body Composition
Cleared on Nov 7, 2006 after a 111-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Nov 7, 2006
- Review
- 111 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK062043 Body Composition Monitor with Scale, Model HBF-500Omron Healthcare, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
- Descendant · 2 generations on · 4 of its ownK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010
- Descendant · 3 generations on · 3 of its ownK110689 InbodyBiospace Corporation Limited · 2011
- Descendant · 4 generations on · 2 of its ownK123228 Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013
- Descendant · 4 generations on · 0 of its ownK141483 Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · cites it directly6descendants
- K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · 2 generations on4descendants
- K110689InbodyBiospace Corporation Limited · 2011 · 3 generations on3descendants
- K123228Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B)Biospace Corporation Limited · 2013 · 4 generations on2descendants
- K141483Biospace Body Composition AnalyzerBiospace Corporation Limited · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062043 | Body Composition Monitor with Scale, Model HBF-500 | Omron Healthcare, Inc. | 2006 | — |
| +1 | K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Corporation Limited | 2007 | — |
| +2 | K092786 | Inbody, Models: 270, R20, R20B | Biospace Corporation Limited | 2010 | — |
| +3 | K110689 | Inbody | Biospace Corporation Limited | 2011 | — |
| +4 | K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B) | Biospace Corporation Limited | 2013 | — |
| +4 | K141483 | Biospace Body Composition Analyzer | Biospace Corporation Limited | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | 2007 | 6 |
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?
- Of its descendants, K062603 (Biospace Corporation Limited, 2007) has gone furthest, with 6 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.
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 Omron HBF-500 body composition monitor with scale is intended to be used to calculate and display the estimated value of body fat percentage, skeletal muscle percentage, resting metabolism, BMI and visceral fat levels using the BI (Bioelectrical Impedance) Method and indicates the BMI (Body Mass Index).
The Omron HBF-500 is intended to be used by healthy individuals in the age range of 18 to 80 years for the skeletal muscle percentage, resting metabolism and visceral fat level. The age range for body fat percentage is intended to be used by healthy individuals between the age of 10 to 80 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062043: Body Composition Monitor with Scale, Model HBF-500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062043
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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