510(k) · Cleared
ClearedInBody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inbody Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 6, 2021 as substantially equivalent to K061456 (A&D Engineering, Inc., 2006) after a 308-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jan 6, 2021
- Review
- 308 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871718 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871718 Modified Model UA-711 Digital SphygmonometerA&D Engineering, Inc. · 1987
- 2 generations backK032499 A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsA&D Engineering, Inc. · 2003
- 1 generation backK061456 A & D Medical UM-101 Digital Blood Pressure MonitorA&D Engineering, Inc. · 2006
- This deviceK200560 InBodyInbody Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871718 | Modified Model UA-711 Digital Sphygmonometer | A&D Engineering, Inc. | 1987 | — |
| −2 | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2003 | — |
| −1 | K061456 | A & D Medical UM-101 Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2006 | — |
| 0 (this device) | K200560 | InBody | Inbody Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K061456 | A & D Medical UM-101 Digital Blood Pressure MonitorSummary page 4…70.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DXQ 2. Equivalent legally marketed device: K061456, A&D Engineering, Inc. Proprietary-Trade Names: A&D Medical UTM-101 Digital Blood Pressure Monitor Regulation Number: 21 CF… | 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 34 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K061456.
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. 2021, 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 subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200560 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200560: InBody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200560
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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