510(k) · Cleared
ClearedKOROT Blood Pressure Monitor (KOROT P3 Accurate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Korot Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 14, 2025 as substantially equivalent to K221764 (Inbody Co., Ltd., 2022) after a 59-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 14, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010828 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK010828 Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VPA&D Engineering, Inc. · 2001
- 3 generations backK131064 BiospaceBiospace Corporation Limited · 2013
- 2 generations backK200442 InBodyInbody Co., Ltd. · 2020
- 1 generation backK221764 InBody Blood pressure monitor, Model BPBIO480KVInbody Co., Ltd. · 2022
- This deviceK250091 KOROT Blood Pressure Monitor (KOROT P3 Accurate)Korot Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010828 | Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP | A&D Engineering, Inc. | 2001 | — |
| −3 | K131064 | Biospace | Biospace Corporation Limited | 2013 | — |
| −2 | K200442 | InBody | Inbody Co., Ltd. | 2020 | — |
| −1 | K221764 | InBody Blood pressure monitor, Model BPBIO480KV | Inbody Co., Ltd. | 2022 | — |
| 0 (this device) | K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K221764 | InBody Blood pressure monitor, Model BPBIO480KVSummary page 5…ly Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221764 Blood Pressure Monitor DXN Device Description Summary… | 2022 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 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. 2025, 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?
This blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250091: KOROT Blood Pressure Monitor (KOROT P3 Accurate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250091
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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