510(k) · Cleared
ClearedBodystat 1500 Body Composition Monitoring Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodystat, Ltd. · MNW Analyzer, Body Composition
Cleared on Nov 25, 2008 as substantially equivalent to K951097 (Bodystat, Ltd., 1995) after a 109-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 25, 2008
- Review
- 109 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951097 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951097 BodystayBodystat, Ltd. · 1995
- This deviceK082253 Bodystat 1500 Body Composition Monitoring UnitBodystat, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951097 | Bodystay | Bodystat, Ltd. | 1995 | — |
| 0 (this device) | K082253 | Bodystat 1500 Body Composition Monitoring Unit | Bodystat, Ltd. | 2008 | — |
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 |
|---|---|---|---|
| * | K951097 | BodystaySummary page 1…nitoring Unit C. Predicate Device: The modified BODYSTAT® 1500 Body Composition Monitoring Unit is substantially equivalent to previously cleared device, K95 1097, Bodystat 1500 Body Composition Monitoring Unit. The BODYSTAT®1500 Body Composition Monitoring Unit device is a hardwar… | 1995 |
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?
- Its one ancestor has no recall.
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?
For the purposes of performing a non-invasive bio-impedance analysis (BIA) measurements on normal healthy human adults to determine their Body Composition status. This device measures bio-electrical impedance when a 50 kHz signal is applied at specific locations on the subject. From this and the subject's age, gender, weight, height, waist and hip circumferences (optional), the device calculates the following estimated values: fat%, fat weight, lean%…
Read the full statement (160 words)
For the purposes of performing a non-invasive bio-impedance analysis (BIA) measurements on normal healthy human adults to determine their Body Composition status.
This device measures bio-electrical impedance when a 50 kHz signal is applied at specific locations on the subject. From this and the subject's age, gender, weight, height, waist and hip circumferences (optional), the device calculates the following estimated values: fat%, fat weight, lean%, lean weight, total body water%, total body water, dry lean weight, basal metabolic rate, basal metabolic rate/body weight ratio, average requirement (EAR), and actual body mass index and waist/hip ratio.
OPTIONAL ACCESSORIES: Bodystat (1) BODY MANAGER and (2) WELLNESS SOFTWARE PROGRAMS. The Body Manager Program is ideal when a client returns to be tested in order to track their changes in body composition over a period of time. The Wellness Program is ideal for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082253 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082253: Bodystat 1500 Body Composition Monitoring Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082253
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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