510(k) · Cleared
ClearedSlimmanager Body Composition Analyzer, Models N40 and SM-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aiia Communication, Inc. · MNW Analyzer, Body Composition
Cleared on Mar 20, 2008 as substantially equivalent to K062603 (Biospace Corporation Limited, 2007) and 1 other predicate after a 126-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Mar 20, 2008
- Review
- 126 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K830292 (1983). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- 4 generations backK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- 3 generations backK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
- 2 generations backK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
- 1 generation backK062603 Biospace Body Composition Analyzers, Model Inbody 230Biospace Corporation Limited · 2007
- This deviceK073227 Slimmanager Body Composition Analyzer, Models N40 and SM-300Aiia Communication, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| −4 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| −3 | K042528 | Inbody, Model 3.0 | Biospace Corporation Limited | 2005 | — |
| −2 | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 | Biospace Corporation Limited | 2005 | — |
| −1 | K062603 | Biospace Body Composition Analyzers, Model Inbody 230 | Biospace Corporation Limited | 2007 | — |
| 0 (this device) | K073227 | Slimmanager Body Composition Analyzer, Models N40 and SM-300 | Aiia Communication, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K062603 | Biospace Body Composition Analyzers, Model Inbody 230Summary page 1…). Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body composition analyzer 2. Equivalent legally marketed devices Biospace InBody 230 K062603; AIIA communication Inc. SLIMMANAGER(SM-X, SM-E) K051589 3. Indications for Use (intended use) (Models SM-300 and N40) For Me… | 2007 |
| * | K051589 | Slimmanager, Model SM-X, SM-ESummary page 1…N Common/Usual Name: Body composition analyzer 2. Equivalent legally marketed devices Biospace InBody 230 K062603; AIIA communication Inc. SLIMMANAGER(SM-X, SM-E) K051589 3. Indications for Use (intended use) (Models SM-300 and N40) For Measurement in healthy subjects of: Estimated: ECW, ICW, TB… | 2005 |
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 25 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 14 ancestors has a recall.
- 1 other device also cites its predicate K062603.
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 Measurement in healthy subjects of:
Estimated: ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass
Actual: Weight, BMI, Impedance Values
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073227 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073227: Slimmanager Body Composition Analyzer, Models N40 and SM-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073227
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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