510(k) · Cleared
ClearedMultifunction Keito
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aguiflai Iberica S.L. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 10, 2011 as substantially equivalent to K811146 (Vita-Stat, 1981) and 3 other predicates after a 392-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 10, 2011
- Review
- 392 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930599 (1994). 5 ancestors in all, the oldest K811146 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930599 | Body Fat Analyzer Model TBF-105 | Tanita Corp. of America | 1994 | — |
| −1 | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale | Tanita Corp. of America | 2002 | — |
| 0 (this device) | K103058 | Multifunction Keito | Aguiflai Iberica S.L. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K811146 | Vita-Stat Model 8000-CSummary page 4…0)(k) code ______________________ reference ___________ Vita-Stat -90550-03 K81 1146 Keito Multifunction K5 K984083 Tanita corp.… | 1981 |
| * | K984083 | Multifunction Keito K5Summary page 2…7. 1.1-Multifunction K7 Test Results. (See Section 18.2 of this 5 10(k) submission) .................... 8 7.1 .2-Multiffinction K5 Test Results. (Submitted on K984083)................................................... 9 7.1.3 -Conclusion..................................................… | 2000 |
| * | K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleSummary page 4…K81 1146 Keito Multifunction K5 K984083 Tanita corp. TBF-300 K014009 Omon Health inc. -HBF-306 K011652 Table ]-Pre… | 2002 |
| * | K011652 | Body Fat Analyzer, Model HBF-306Summary page 4…K984083 Tanita corp. TBF-300 K014009 Omon Health inc. -HBF-306 K011652 Table ]-Predicateswe consider equivalence, 4-Description of the Device [2ICFR§ 807.92(a)(4)… | 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 17 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Multifunction Keito devices are intended to be used by general public without prescription, operated with coins, to measure personal health parameters such as weight, height, estimation of body fat index, blood pressure, and pulse rate. Multifunction Keito can be installed in pharmacies or in other public sites. It is not a diagnostic device, and only offers data that users can consult with their personal physicians. The results are either printed on a ticket or saved on a card.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103058: Multifunction Keito.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103058
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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