510(k) · Cleared
ClearedBestshape Blood Pressure Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wistron Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 22, 2011 as substantially equivalent to K051703 (Taidoc Technology Corporation, 2005) after a 71-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Nov 22, 2011
- Review
- 71 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021239 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021239 Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 2002
- 2 generations backK040159 Apm Blood Pressure Monitor, Model BP108AAsia Pacific Microsystems, Inc. · 2004
- 1 generation backK051703 Clever TD-3018A Blood Pressure MonitorTaidoc Technology Corporation · 2005
- This deviceK112647 Bestshape Blood Pressure Monitoring SystemWistron Corporation · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021239 | Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M | Eikon Healthcare Device Corp. | 2002 | — |
| −2 | K040159 | Apm Blood Pressure Monitor, Model BP108A | Asia Pacific Microsystems, Inc. | 2004 | — |
| −1 | K051703 | Clever TD-3018A Blood Pressure Monitor | Taidoc Technology Corporation | 2005 | — |
| 0 (this device) | K112647 | Bestshape Blood Pressure Monitoring System | Wistron Corporation | 2011 | — |
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 |
|---|---|---|---|
| * | K051703 | Clever TD-3018A Blood Pressure MonitorSummary page 1…8Am Blood Pressure Monitor Common/Usual Name: Blood pressure test system Submitter Taifloc Technology Corporation 510 Qk) Number K051703 XOUJNDA(rt)… | 2005 |
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 9 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K051703.
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 BestShape system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings. The measurement position of the device is the wrist of the subject. This system should be used for the testing on people Over age of 18.
The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112647: Bestshape Blood Pressure Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112647
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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