510(k) · Cleared
ClearedBody Analysis Scale, Model BG 17
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Healthcare Electronic Technology Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Jul 15, 2011 as substantially equivalent to K040778 (Tanita Corp. of America, 2004) after a 102-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 15, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930599 (1994). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK110928 Body Analysis Scale, Model BG 17Shenzhen Healthcare Electronic Technology Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK120896 WI-FI Body ScaleAndon Health Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK121527 WI-FI Body ScaleShenzhen Healthcare Electronic Technology Co., Ltd. · 2012
Most influential descendants
Showing 2 of 2 · See allView 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) | K110928 | Body Analysis Scale, Model BG 17 | Shenzhen Healthcare Electronic Technology Co., Ltd. | 2011 | — |
| +1 | K120896 | WI-FI Body Scale | Andon Health Co, Ltd. | 2012 | — |
| +1 | K121527 | WI-FI Body Scale | Shenzhen Healthcare Electronic Technology Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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? (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…Common Name :Body Analysis scale/ Electronic Body Fat Scale Classification Name :Impedance plethysmograph 3. Predicate Devices: Tanita BC-533, (K040778) 4. Classifications Names & Citations: 21 CFR 870.2770, MNW, Body Fat Analyzer, Class2… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120896 (Andon Health Co, Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 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 Shenzhen Healthcare Electronic Technology Body analysis scale, Model BG 17 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110928: Body Analysis Scale, Model BG 17.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110928
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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