510(k) · Cleared
ClearedHuibao Body Fat Scale
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhongshan Huibao Weighing Apparatus Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Oct 7, 2011 as substantially equivalent to K040778 (Tanita Corp. of America, 2004) after a 141-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Oct 7, 2011
- Review
- 141 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930599 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 2 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 1 generation backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- This deviceK111404 Huibao Body Fat ScaleZhongshan Huibao Weighing Apparatus Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −2 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −1 | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) | Tanita Corp. of America | 2004 | — |
| 0 (this device) | K111404 | Huibao Body Fat Scale | Zhongshan Huibao Weighing Apparatus Co., Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)Summary page 1…Number (Code) :21 CFR/Part 870.2770(MNW) 3. Information of the 510(k) Cleared Device (Predicate Device): TANITA InnerSoan Body Composition Monitor model BC-534(K040778) 4. Device Description: The Huibao BF-l 36 Body Fat Scale is a program-controlled body composition analyzer that utilizes… | 2004 |
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 17 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- 9 other devices also cite its predicate K040778.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Huibao BE-i 36 Body Fat Scale measures body weight and impedance for the person standing on the four foot electrodes, and then estimates and displays the information of body weight, total body fat percentage, total body water percentage, bone mass, and daily calorie intake(DCI) using Foot-to-Foot BIA(bioelectrical impedance analysis) method. BF-1 36 is intended for the healthy person whose age is between 10 and 80 years old
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111404: Huibao Body Fat Scale.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111404
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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