510(k) · Cleared
ClearedBody Fat Analyzer, Model HBF-306
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, 2001 after a 162-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.
- Decided
- Nov 7, 2001
- Review
- 162 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 12 citing it directly.
- This deviceK011652 Body Fat Analyzer, Model HBF-306Omron Healthcare, Inc. · 2001
- Descendant · cites it directly · 11 of its ownK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- Descendant · 2 generations on · 10 of its ownK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
- Descendant · 3 generations on · 8 of its ownK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
- Descendant · 3 generations on · 6 of its ownK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
- Descendant · 4 generations on · 4 of its ownK092786 Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K023478Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003 · cites it directly11descendants
- K042528Inbody, Model 3.0Biospace Corporation Limited · 2005 · 2 generations on10descendants
- K052646Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005 · 3 generations on8descendants
- K062603Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007 · 3 generations on6descendants
- K092786Inbody, Models: 270, R20, R20BBiospace Corporation Limited · 2010 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011652 | Body Fat Analyzer, Model HBF-306 | Omron Healthcare, Inc. | 2001 | — |
| +1 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| +2 | K042528 | Inbody, Model 3.0 | Biospace Corporation Limited | 2005 | — |
| +3 | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 | Biospace Corporation Limited | 2005 | — |
| +3 | K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Corporation Limited | 2007 | — |
| +4 | K092786 | Inbody, Models: 270, R20, R20B | Biospace Corporation Limited | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (23)
See all 2312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023478 | Inbody AP1 Body Composition Analyzer | 2003 | 11 |
| K030203 | Long Well LW-6DXX Series Body Fat Analyzer | 2003 | 3 |
| K103058 | Multifunction Keito | 2011 | 0 |
| K060552 | BC100 Body Composition Analysis System | 2006 | 0 |
| K052678 | AQ-830 Slim Body, Body Fat Monitor | 2005 | 0 |
| K052522 | Stayhealthy Body Composition Analyzer, Models BC1 and BC2 | 2005 | 0 |
| K043414 | HL 188 & HL 189 Body Fat Meter | 2005 | 0 |
| K031582 | Wrist Blood Pressure Monitor & Fat Meter, Model WT-20 | 2003 | 0 |
| K023817 | Smartshape Body Composition Analyzer, Model 4010 | 2003 | 0 |
| K020738 | Avita BF1 (Vitalio) Body Fat Analyzer | 2003 | 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?
- Of its descendants, K023478 (Biospace Co.,Ltd, 2003) has gone furthest, with 11 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 device Is noninvasive bioimpedance analyzer for use in estimating human's body fat volume (mass) and percentage by weight. The applicable age range is 10 to 80 years for normal subjects and 18 to 60 years for athletic subjects.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011652: Body Fat Analyzer, Model HBF-306.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011652
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026