510(k) · Cleared
ClearedHealthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonso Electronics International, Inc. · MNW Analyzer, Body Composition
Cleared on May 2, 2003 as substantially equivalent to K014009 (Tanita Corp. of America, 2002) after an 88-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- May 2, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930599 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 1 generation backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- This deviceK030349 Healthometer Professional Body Fat Monitor and Scale, Models BFM…Bonso Electronics International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK081587 Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530Krell Precision (Yang Zhou) Co., Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081587Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530Krell Precision (Yang Zhou) Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −1 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| 0 (this device) | K030349 | Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945… | Bonso Electronics International, Inc. | 2003 | — |
| +1 | K081587 | Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530 | Krell Precision (Yang Zhou) Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 |
|---|---|---|---|
| * | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081587 | Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530 | 2008 | 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081587 (Krell Precision (Yang Zhou) Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K014009.
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 Bonso Electronics Int’l., Inc., Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960 are indicated to measure body weight and impedance and estimate body fat percent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030349: Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030349
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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