510(k) · Cleared
ClearedWrist Blood Pressure Monitor & Fat Meter, Model WT-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Seimitsu Sokki Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Aug 1, 2003 as substantially equivalent to K011652 (Omron Healthcare, Inc., 2001) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 1, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003444 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003444 Model WS-500 Digital Wrist Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2000
- This deviceK031582 Wrist Blood Pressure Monitor & Fat Meter, Model WT-20Nihon Seimitsu Sokki Co., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003444 | Model WS-500 Digital Wrist Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2000 | — |
| 0 (this device) | K031582 | Wrist Blood Pressure Monitor & Fat Meter, Model WT-20 | Nihon Seimitsu Sokki Co., Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K011652 | Body Fat Analyzer, Model HBF-306 | 2001 |
| * | K003444 | Model WS-500 Digital Wrist Blood Pressure MonitorSummary page 1…nalyzer KO 11652, and has the blood pressures and pulse rate measurement of Nihon Seimitsu Sokki Co., Ltd. (Nissei) WS-500 Digital Wrist Blood Pressure Monitor K003444. 3. Indications for Use (intended use) Combination unit for measuring systolic and diastolic blood pressures and pulse ra… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 11 other devices also cite its predicate K011652.
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?
Combination unit for measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 4.9” to 8’’ inches as well as body composition, i.e. estimation of body fat, a noninvasive bioimpedance analyzer for use in estimating the human’s body fat volume (mass) and percentage by weight. Age range 10-80 years normal subjects, 18-80 years for athletic subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031582: Wrist Blood Pressure Monitor & Fat Meter, Model WT-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031582
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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