510(k) · Cleared
ClearedHL 188 & HL 189 Body Fat Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health & Life Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Feb 9, 2005 as substantially equivalent to K030203 (Long Well Electronics Corp., 2003) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Feb 9, 2005
- Review
- 58 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011652 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K030203 | Long Well LW-6DXX Series Body Fat AnalyzerSummary page 1…Mr. Paul Yang / President 2.0 Device Name: HEALTH & LIFE HL 188 & HL 189 BODY FAT METER 3.0 Predicate Device: * LONG WELL LW-6Dxx Body Fat Analyzer (K030203) marketed by LONG WELL ELECTRONICS CORP. & · Omron HBF-306 Body Fat Analyzer… | 2003 |
| * | K011652 | Body Fat Analyzer, Model HBF-306Summary page 1…L LW-6Dxx Body Fat Analyzer (K030203) marketed by LONG WELL ELECTRONICS CORP. & · Omron HBF-306 Body Fat Analyzer ( K01 1652 )marketed by Omron Healthcare INC. 4.0 Device Description: HEALTH & LIFE HL 188 & HL 189 BODY FAT MET… | 2001 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K030203.
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 device is a noninvasive bioimpedance meter used to estimate body fat percentage in the home setting. The device is for normal, healthy people only, and the applicable age range is 10 to 80 years old.
The device is to be used in a home environment having normal temperature and humidity conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043414: HL 188 & HL 189 Body Fat Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043414
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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