510(k) · Cleared
ClearedBody Composition Analyzer, Models Zeus 9.9 and Venus 5.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jawon Medical Co., Ltd. · MNW Analyzer, Body Composition
Cleared on Aug 31, 2006 as substantially equivalent to K002835 (Bodystat, Ltd., 2001) and 1 other predicate after a 254-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Aug 31, 2006
- Review
- 254 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. 4 later devices descend from it, 2 citing it directly.
- 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 backK033157 Tanita Segmental Body Composition Analyzer, Model BC-418Tanita Corp. of America · 2004
- This deviceK053556 Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5Jawon Medical Co., Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK071884 Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus…Jawon Medical Co., Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK092431 Body Composition Analyzer, Model: Ioi 353Jawon Medical Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK072325 Body Composition Analyzer, Easybody 202, 203, 205Jawon Medical Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK140045 Body Composition AnalyzerJawon Medical Co., Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K071884Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia…Jawon Medical Co., Ltd. · 2007 · cites it directly2descendants
- K092431Body Composition Analyzer, Model: Ioi 353Jawon Medical Co., Ltd. · 2009 · 2 generations on1descendant
- K072325Body Composition Analyzer, Easybody 202, 203, 205Jawon Medical Co., Ltd. · 2007 · cites it directly1descendant
- K140045Body Composition AnalyzerJawon Medical Co., Ltd. · 2015 · 2 generations on0descendants
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 | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418 | Tanita Corp. of America | 2004 | — |
| 0 (this device) | K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5 | Jawon Medical Co., Ltd. | 2006 | — |
| +1 | K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis… | Jawon Medical Co., Ltd. | 2007 | — |
| +2 | K092431 | Body Composition Analyzer, Model: Ioi 353 | Jawon Medical Co., Ltd. | 2009 | — |
| +1 | K072325 | Body Composition Analyzer, Easybody 202, 203, 205 | Jawon Medical Co., Ltd. | 2007 | — |
| +2 | K140045 | Body Composition Analyzer | Jawon Medical Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K002835 | BodystatSummary page 1…SITION ANALYZER, Impedance piethysniograph, MNW 3- PREDICATE DEVICE. BODYSTAT Quad scan 4000 Body Composition Analyzer, K002835, decision on 07/03/2001 TANITA Body Composition Analyzer BC-418, K033157, decision on 08/08/2004 4. DEVICE DESCRIPT… | 2001 |
| * | K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418Summary page 1…h, MNW 3- PREDICATE DEVICE. BODYSTAT Quad scan 4000 Body Composition Analyzer, K002835, decision on 07/03/2001 TANITA Body Composition Analyzer BC-418, K033157, decision on 08/08/2004 4. DEVICE DESCRIPTION. general: Model ZEUS 9.9NENUS 5.5 of Jawon Medical is compact, automa… | 2004 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K071884 (Jawon Medical Co., Ltd., 2007) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K002835.
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 ZEUS 9.9 and VENUS 5.5 body composition analyzers are intended to estimate PBF(Percentage of Body Fat), MB3F(Mass of Body Fat), LBM(Lean Body Mass), TBW(Totnl Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECWITr3W using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, arid…
Read the full statement (128 words)
The ZEUS 9.9 and VENUS 5.5 body composition analyzers are intended to estimate PBF(Percentage of Body Fat), MB3F(Mass of Body Fat), LBM(Lean Body Mass), TBW(Totnl Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECWITr3W using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, arid WHR@Vaist to Hip Ratio) of the user-
These devices are Intended for use only in healthy subjects between the age of 7-89.
The only difference between the ZEUS 9.9 and VENUS &-5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screenL
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053556 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053556: Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053556
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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