510(k) · Cleared

Cleared

Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and 9568

K060538510(k) TraditionalCleared Oct 10, 2006224-day reviewClass II21 CFR 870.2770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beaverite International Limited · MNW Analyzer, Body Composition

Cleared on Oct 10, 2006 as substantially equivalent to K040778 (Tanita Corp. of America, 2004) after a 224-day review. Its family tree reaches back 3 generations to 1994.

Decided: Oct 10, 2006
Review: 224 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.

By dateBy generation

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 deviceK060538 Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911…Beaverite International Limited · 2006

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)	K060538	Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and…	Beaverite International Limited	2006	—

FIG. 1 — Lineage of K060538, 1994–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K040778	Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) Summary page 1 …Plethysmograph Classification Number: 21 CFR 870.2770 Product Code: MNW Predicate Device: Tanita Innerscan Body Composition Monitor, K040778 Statement of The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9…	Tanita Corp. of America	2004	—

Also cleared against K040778: 9 other devices →

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 12 years and passes through 2 companies; a new generation was cleared every 2.5 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 devices

MNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNW

1in 2024

2007high 11 (2011) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNW

110in 2014

2007high 168 (2011) · low 103 (2012)2026

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

2007high 16 (2018) · low 0 (2007)2025

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	MAUDE reports
2007	4	109	0
2008	4	134	0
2009	4	137	0
2010	1	—	1
2011	11	168	0
2012	4	103	0
2013	9	144	0
2014	3	110	0
2015	1	—	2
2016	0	—	15
2017	0	—	6
2018	0	—	16
2019	0	—	11
2020	0	—	12
2021	0	—	10
2022	0	—	8
2023	0	—	2
2024	1	—	3
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -- measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults.

The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060538 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060538: Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and 9568.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060538

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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