510(k) · Cleared
ClearedKrell Weight & Body Fat Monitoring Scale, Model Bfa-8530
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Krell Precision (Yang Zhou) Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Oct 24, 2008 as substantially equivalent to K040778 (Tanita Corp. of America, 2004) and 1 other predicate after a 141-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Oct 24, 2008
- Review
- 141 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930599 (1994). 4 ancestors in all. 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 backK030349 Healthometer Professional Body Fat Monitor and Scale, Models BFM…Bonso Electronics International, Inc. · 2003
- This deviceK081587 Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530Krell Precision (Yang Zhou) Co., Ltd. · 2008
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 | K030349 | Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945… | Bonso Electronics International, Inc. | 2003 | — |
| 0 (this device) | K081587 | Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530 | Krell Precision (Yang Zhou) Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (2)
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…8530 Common Name :Analyzer, Body Fat Classification Name :Impedance plethysmograph 3. Predicate Devices : Tanita BC-533, (K040778); Bonso Health o meter BMF583 4. Classifications Names & Citations: 21 CFR 870.2770, MNW, Body Fat Analyzer, Class2 ===… | 2004 |
| * | K030349 | Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960Summary page 3…on (Yang Zhou) Co., LTD, believes that the Krell Weight and Body Fat Scale is substantially equivalent to the Tanita BC-533 (K040778), Bonso Health o meter Model BFM583 (K030349) 8. Safety and Performance Data Electrical, mechanical, environmental safety and performance testing according… | 2003 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 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. 2008, 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 KRELL Weight & Body Fat Monitoring Scale is indicated to measure body weight and impedance and estimate the percentage of Body Fat and body water, Bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults and children (from age 10 and up) 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/K081587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081587: Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081587
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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