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 Dec 4, 2020 as substantially equivalent to K131064 (Biospace Corporation Limited, 2013) after a 284-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 4, 2020
- Review
- 284 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010828 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010828 Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VPA&D Engineering, Inc. · 2001
- 1 generation backK131064 BiospaceBiospace Corporation Limited · 2013
- This deviceK200442 InBodyInbody Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK221764 InBody Blood pressure monitor, Model BPBIO480KVInbody Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK250091 KOROT Blood Pressure Monitor (KOROT P3 Accurate)Korot Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010828 | Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP | A&D Engineering, Inc. | 2001 | — |
| −1 | K131064 | Biospace | Biospace Corporation Limited | 2013 | — |
| 0 (this device) | K200442 | InBody | Inbody Co., Ltd. | 2020 | — |
| +1 | K221764 | InBody Blood pressure monitor, Model BPBIO480KV | Inbody Co., Ltd. | 2022 | — |
| +2 | K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K131064 | BiospaceSummary page 4…Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Meter Regulatory Class: Class II Product Code: DXN 2. Equivalent legally marketed device: K131064, Biospace Corporation Limited (Former company name) Proprietary-Trade Names: BPBIO320/BPBIO320n Common/Usual Name: Blood… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221764 | InBody Blood pressure monitor, Model BPBIO480KV | 2022 | 1 |
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 12.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221764 (Inbody Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K131064.
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. 2020, 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 Inbody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm.
The models of BP170, BP170B, BP160 and BP160B are designated as both Prescription use and Over-the-counter use.
The model of BPBIO250 is designated as Prescription use only.
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/K200442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200442: InBody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200442
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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