510(k) · Cleared
ClearedAmbulatory Blood Pressure Monitor, Models FB-270 and DS-270
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Seimitsu Sokki Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 3, 2010 as substantially equivalent to K913595 (Koven and Assoc., Inc., 1992) and 1 other predicate after a 245-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jun 3, 2010
- Review
- 245 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913595 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK913595 DS-240 Ambulatory Blood Pressure Monitoring SystemKoven and Assoc., Inc. · 1992
- This deviceK093102 Ambulatory Blood Pressure Monitor, Models FB-270 and DS-270Nihon Seimitsu Sokki Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913595 | DS-240 Ambulatory Blood Pressure Monitoring System | Koven and Assoc., Inc. | 1992 | — |
| 0 (this device) | K093102 | Ambulatory Blood Pressure Monitor, Models FB-270 and DS-270 | Nihon Seimitsu Sokki Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (2)
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 |
|---|---|---|---|
| * | K913595 | DS-240 Ambulatory Blood Pressure Monitoring SystemSummary page 1…on: Class I, 74 DXN, 21 CFR 870.1130 - Cardiovascular devices panel (3) The predicate devices: KOVEN AND ASSOC., INC DS-240 Ambulatory Blood pressure monitoring System, K913595 A&D Medical TM-2430 and TM 2431 Ambulatory Blood pressure monitors,K992808 (4) Description of the device: Ambulatory Blood Pres… | 1992 |
| * | K992808 | A&D Medical TM-2430 and TM-2431 Ambulatory Blood PressureSummary page 1…predicate devices: KOVEN AND ASSOC., INC DS-240 Ambulatory Blood pressure monitoring System, K913595 A&D Medical TM-2430 and TM 2431 Ambulatory Blood pressure monitors,K992808 (4) Description of the device: Ambulatory Blood Pressure Monitor FB8-270/DS-270 Ambulatory Blood Pressure Monitor FB-270/DS-270… | 1999 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K913595.
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. 2010, 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?
FB-270/DS-270 is a portable blood pressure monitor for non-invasive blood pressure measurement, monitoring intraday variance of blood pressure in dally life. They measure systolic and diastolic blood pressure and heart rate, at set interval within 24/48 hours c;r manually, and store the data to SD card (memory card).
The collected data can ensure the change in the day of the blood pressure in the personal computer using CD-ROM for exclusive setup.
Physicians at medical institutions will check the data on personal computer for analysis of
- hypertensive and hypoter}sive diseases.
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/K093102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093102: Ambulatory Blood Pressure Monitor, Models FB-270 and DS-270.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093102
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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