510(k) · Cleared
ClearedAneroid Sphygmomanometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiaxing Zhongfa Medical Products Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Jun 30, 2015 as substantially equivalent to K092245 (Honsun (Nantong) Co., Ltd., 2009) after a 50-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jun 30, 2015
- Review
- 50 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060871 (2006). No later device cites it as a predicate yet.
- Root · 2 generations backK060871 AS101, Blood Pressure CuffWenzhou Longwan Medical Instrument Company · 2006
- 1 generation backK092245 Aneroid Sphygmomanometer with Stethoscope, Model LD-100Honsun (Nantong) Co., Ltd. · 2009
- This deviceK151246 Aneroid SphygmomanometerJiaxing Zhongfa Medical Products Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060871 | AS101, Blood Pressure Cuff | Wenzhou Longwan Medical Instrument Company | 2006 | — |
| −1 | K092245 | Aneroid Sphygmomanometer with Stethoscope, Model LD-100 | Honsun (Nantong) Co., Ltd. | 2009 | — |
| 0 (this device) | K151246 | Aneroid Sphygmomanometer | Jiaxing Zhongfa Medical Products Co., Ltd. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K092245 | Aneroid Sphygmomanometer with Stethoscope, Model LD-100Summary page 6…K151246 Page 3 of 5 Predicate Device K092245 Aneroid Sphygmomanometer with Stethoscope, Model LD-100 HONSUN(NANTONG) CO., LTD. 6. Non-Clinical Test Conclusion… | 2009 |
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 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The Aneroid Sphygmomanometer is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home to monitor both systolic and diastolic pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151246: Aneroid Sphygmomanometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151246
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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