510(k) · Cleared
ClearedAccutension Smartphone Auscultatory Blood
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Hulu Devices Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Mar 8, 2018 as substantially equivalent to K043286 (Wenzhou Bokang Instrument Co.,Ltd, 2005) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Mar 8, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K790810 (1979). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 3 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 2 generations backK012194 Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001
- 1 generation backK043286 Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005
- This deviceK180335 Accutension Smartphone Auscultatory BloodShanghai Hulu Devices Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −3 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −2 | K012194 | Blood Pressure Monitor (Sphygmomanometer), Model HT-110 | Nihon Seimitsu Sokki Co., Ltd. | 2001 | — |
| −1 | K043286 | Aneroid Sphygmomanometer, Model BK2002 | Wenzhou Bokang Instrument Co.,Ltd | 2005 | — |
| 0 (this device) | K180335 | Accutension Smartphone Auscultatory Blood | Shanghai Hulu Devices Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 DXQ? 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 DXQ device
- #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.3 · 7 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 |
|---|---|---|---|
| * | K043286 | Aneroid Sphygmomanometer, Model BK2002Summary page 4…Blood Pressure Cuff Product Code: DXQ, DQD 5.1 Predicate Device Aneroid Sphygmomanometer BK2002 (Wenzhou Bokang Instrument Co., Ltd, K043286) is used as a predicate device compared to Accutension Smartphone Auscultatory Blood Pressure Kit on blood pressure measurement.… | 2005 |
| * | K133383 | HEM-7320Summary page 4…43286) is used as a predicate device compared to Accutension Smartphone Auscultatory Blood Pressure Kit on blood pressure measurement. HEM-7320 (OMRON HEALTHCARE, INC., K133383) is used as a predicate device compared to Accutension Smartphone Auscultatory Blood Pressure Kit on pulse rate measurement. 5.2… | 2014 |
| † | K142743 | AliveCor Heart Monitor | 2015 |
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 39 years and passes through 5 companies; a new generation was cleared every 13.1 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K043286.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DXQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXQ
174in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXQ
20in 2025
MAUDE reports naming product code DXQ, 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 | 2 | — | 0 | 3 |
| 2008 | 7 | 118 | 0 | 4 |
| 2009 | 5 | 57 | 0 | 2 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 121 | 1 | 5 |
| 2012 | 4 | 102 | 0 | 7 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 4 | 105 | 0 | 9 |
| 2015 | 10 | 59 | 0 | 23 |
| 2016 | 4 | 217 | 0 | 50 |
| 2017 | 2 | — | 0 | 67 |
| 2018 | 5 | 225 | 0 | 44 |
| 2019 | 3 | 44 | 0 | 41 |
| 2020 | 3 | 207 | 0 | 5 |
| 2021 | 4 | 105 | 0 | 12 |
| 2022 | 4 | 105 | 0 | 3 |
| 2023 | 5 | 79 | 0 | 20 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 3 | 174 | 1 | 20 |
| 2026 | 4 | 102 | 0 | — |
What is it indicated for?
Accutension Smartphone Auscultatory Blood Pressure Kit is intended for professionals or home users to nonautomatically measure systolic and diastolic blood pressure on adults by detecting Korotkoff sounds and measure pulse rate on adults by detecting oscillometry. This device is not indicated for children, heart failure patients and critical patients.
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/K180335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180335: Accutension Smartphone Auscultatory Blood.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180335
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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