510(k) · Cleared
ClearedAneroid Sphygmomanometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzhou Kangshun Medical Devices Co.,Ltd · DXQ Blood Pressure Cuff
Cleared on Jun 28, 2023 as substantially equivalent to K212416 (Wenzhou Xikang Medical Instruments Co., Ltd., 2022) after a 91-day review. Its family tree reaches back 7 generations to 1979.
- Decided
- Jun 28, 2023
- Review
- 91 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K790810 (1979). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 6 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 5 generations backK012194 Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001
- 4 generations backK043286 Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005
- 3 generations backK173246 Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018
- 2 generations backK190902 RH non-Automated Blood Pressure Meter RH non-Automated Blood…Wenzhou Renhua Instruments Co., Ltd. · 2019
- 1 generation backK212416 WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated…Wenzhou Xikang Medical Instruments Co., Ltd. · 2022
- This deviceK230859 Aneroid SphygmomanometerWenzhou Kangshun Medical Devices Co.,Ltd · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −6 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −5 | K012194 | Blood Pressure Monitor (Sphygmomanometer), Model HT-110 | Nihon Seimitsu Sokki Co., Ltd. | 2001 | — |
| −4 | K043286 | Aneroid Sphygmomanometer, Model BK2002 | Wenzhou Bokang Instrument Co.,Ltd | 2005 | — |
| −3 | K173246 | Aneroid Sphygmomanometer | Wenzhou Bokang Instruments Co., Ltd. | 2018 | — |
| −2 | K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter… | Wenzhou Renhua Instruments Co., Ltd. | 2019 | — |
| −1 | K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood… | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022 | — |
| 0 (this device) | K230859 | Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter…Summary page 4…2 2.Predicate Device Information Common Name: WX non-Automated Blood Pressure Meter Regulation Name: Blood Pressure Cuff 510(k) number: K212416 Product Code: DXQ Regulation Number: 21 CFR 870.1120 Regulation Class: 2 3.Device Description The pr… | 2022 |
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 44 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
There are a variety of stethoscopes can be an optioned accessory,depending on the model.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230859: 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/K230859
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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