510(k) · Cleared
ClearedSeca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seca GmbH & Co. KG · MNW Analyzer, Body Composition
Cleared on May 2, 2013 as substantially equivalent to K052646 (Biospace Corporation Limited, 2005) after a 269-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- May 2, 2013
- Review
- 269 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K830292 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK830292 Bioelectrical Impedance Analyzer #101Rjl Systems, Inc. · 1983
- 3 generations backK023478 Inbody AP1 Body Composition AnalyzerBiospace Co.,Ltd · 2003
- 2 generations backK042528 Inbody, Model 3.0Biospace Corporation Limited · 2005
- 1 generation backK052646 Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Biospace Corporation Limited · 2005
- This deviceK122388 Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca…Seca GmbH & Co. KG · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830292 | Bioelectrical Impedance Analyzer #101 | Rjl Systems, Inc. | 1983 | — |
| −3 | K023478 | Inbody AP1 Body Composition Analyzer | Biospace Co.,Ltd | 2003 | — |
| −2 | K042528 | Inbody, Model 3.0 | Biospace Corporation Limited | 2005 | — |
| −1 | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 | Biospace Corporation Limited | 2005 | — |
| 0 (this device) | K122388 | Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514 | Seca GmbH & Co. KG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20Summary page 1…Class 11 Classification Code: MNW - Analyzer, Body Composition Regulation number: 21 CFR 870.2770 510(k) number: K052646 4 Device Description The seca mBCA 514 is a scale and impedance plethysmograph body composition analyzer far estimation of the… | 2005 |
| † | K052581 | Lunar Idxa | 2005 |
| † | K060848 | Bod Pod | 2006 |
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 30 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K052646.
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 seca mECA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages. In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water…
Read the full statement (140 words)
The seca mECA 514 measures body Weight and records body Height for calculation of Body
Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to
monitor growth process and weight changes in individuals of all ages.
In healthy individuals aged 18 years and older the device also measures body impedance
(Reactance Xc and Resistance R) for estimation of body composition. Estimation of body
composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular
Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (PPM), Fat Mass (FM), Fat Mass Indices
(EMI and FMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis
(BIVA), Energy stored in body (Ewy) and Phase Angle (0).
The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca
analytics 115 for data management, calculations and display of information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122388: Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122388
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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