510(k) · Cleared
ClearedPrecision One Lifecare; Detecto; Detecto
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision One Lifecare, Ltd. · MNW Analyzer, Body Composition
Cleared on Sep 26, 2013 as substantially equivalent to K090479 (Tanita Corporation of America, 2009) after a 174-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Sep 26, 2013
- Review
- 174 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930599 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK930599 Body Fat Analyzer Model TBF-105Tanita Corp. of America · 1994
- 3 generations backK014009 Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita…Tanita Corp. of America · 2002
- 2 generations backK040778 Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0…Tanita Corp. of America · 2004
- 1 generation backK090479 Tanita Body Composition Analyzer, Model SC-331Tanita Corporation of America · 2009
- This deviceK130952 Precision One Lifecare; Detecto; DetectoPrecision One Lifecare, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −3 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| −2 | K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) | Tanita Corp. of America | 2004 | — |
| −1 | K090479 | Tanita Body Composition Analyzer, Model SC-331 | Tanita Corporation of America | 2009 | — |
| 0 (this device) | K130952 | Precision One Lifecare; Detecto; Detecto | Precision One Lifecare, Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K090479 | Tanita Body Composition Analyzer, Model SC-331Summary page 2…of 5 Substantial equivalence: The Precision One Lifecare and Detecto Body Fat scales are substantially equivalent to: Tanita Model: SC331 - Body Composition Analyzer (1(090479) Precision One Lifecare * Removable Remote Glass LCD Digital Body Fat/Body Composition: 7 in 1 Analysis, Model 7853 (EF932)… | 2009 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K090479.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only. Estimated body fat percent is intended for use on…
Read the full statement (173 words)
The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only.
Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults). Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old.
Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only. The scales are not intended for diagnosis.
The specific model names and numbers for these scales are:
Precision One Lifecare model numbers - 7853, 7840, 7841, 7850, 7851, and 7856.
Detecto model numbers - D221, D222, D223, D212, D207, D201, D202, D203, D204, and D205
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130952: Precision One Lifecare; Detecto; Detecto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130952
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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