510(k) · Cleared
ClearedClever TD-3018A Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 12, 2005 as substantially equivalent to K040159 (Asia Pacific Microsystems, Inc., 2004) after a 49-day review. Its family tree reaches back 2 generations to 2002. 8 later devices descend from it.
- Decided
- Aug 12, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021239 (2002). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK021239 Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 2002
- 1 generation backK040159 Apm Blood Pressure Monitor, Model BP108AAsia Pacific Microsystems, Inc. · 2004
- This deviceK051703 Clever TD-3018A Blood Pressure MonitorTaidoc Technology Corporation · 2005
- Descendant · cites it directly · 4 of its ownK051907 InnocorInnovision A/S · 2006
- Descendant · 2 generations on · 3 of its ownK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- Descendant · 2 generations on · 2 of its ownK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- Descendant · 2 generations on · 0 of its ownK190561 NICU V'02Cosmed Nordic Aps · 2020
- Descendant · cites it directly · 0 of its ownK112647 Bestshape Blood Pressure Monitoring SystemWistron Corporation · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K051907InnocorInnovision A/S · 2006 · cites it directly4descendants
- K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007 · 2 generations on3descendants
- K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S · 2009 · 2 generations on2descendants
- K190561NICU V'02Cosmed Nordic Aps · 2020 · 2 generations on0descendants
- K112647Bestshape Blood Pressure Monitoring SystemWistron Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021239 | Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M | Eikon Healthcare Device Corp. | 2002 | — |
| −1 | K040159 | Apm Blood Pressure Monitor, Model BP108A | Asia Pacific Microsystems, Inc. | 2004 | — |
| 0 (this device) | K051703 | Clever TD-3018A Blood Pressure Monitor | Taidoc Technology Corporation | 2005 | — |
| +1 | K051907 | Innocor | Innovision A/S | 2006 | — |
| +2 | K071911 | Cardiopulmonary Exercise Testing Option to Innocor | Innovision A/S | 2007 | — |
| +2 | K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including… | Innovision A/S | 2009 | — |
| +2 | K190561 | NICU V'02 | Cosmed Nordic Aps | 2020 | — |
| +1 | K112647 | Bestshape Blood Pressure Monitoring System | Wistron Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K040159 | Apm Blood Pressure Monitor, Model BP108ASummary page 1…nt System Classification Name: blood pressure monitor Class 11 devices, 21 CFR 870.1130 Manufacturer: Asia Pacific Microsystems, Inc. 510 (k) Number: K040159 3. Device Description The CLEVER TD-3018ATM Blood Pressure Monitor is a wrist blood pressure monitor and uses the oscillometric… | 2004 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051907 (Innovision A/S, 2006) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K040159.
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.
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 Clever TD-3018A Blood Pressure Monitor provide intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"-7.75".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051703: Clever TD-3018A Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051703
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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