510(k) · Cleared
ClearedBlood Pressure Monitor with Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Reli-On Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Sep 24, 2012 as substantially equivalent to K081951 (Wenzhou Kindcare Import & Export Co., Ltd., 2008) after a 59-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Sep 24, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081951 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK081951 Aneroid Sphygmomanometer, Model KT-A01Wenzhou Kindcare Import & Export Co., Ltd. · 2008
- This deviceK122259 Blood Pressure Monitor with StethoscopeHangzhou Reli-On Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081951 | Aneroid Sphygmomanometer, Model KT-A01 | Wenzhou Kindcare Import & Export Co., Ltd. | 2008 | — |
| 0 (this device) | K122259 | Blood Pressure Monitor with Stethoscope | Hangzhou Reli-On Co., Ltd. | 2012 | — |
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 |
|---|---|---|---|
| * | K081951 | Aneroid Sphygmomanometer, Model KT-A01Summary page 1…Pressure Cuff Classification Name :Blood Pressure Cuff 3. Predicate Device: The predicate device is: Wenzhou Kindcare Import & Export Co., Ltd K081951 Aneroid Sphygmomanometer, Model KT-AO1 Recognized Consensus Standards: The following standard was used to demonstrate… | 2008 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K081951.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Blood pressure monitor with stethoscope, Model HBPK-A is a non-automated, aneroid blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospital or at home to monitor both systolic and diastolic pressure. This device is sold with an adult O-ring cuff and suitable for use on adult.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122259: Blood Pressure Monitor with Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122259
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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