510(k) · Cleared
ClearedRH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzhou Renhua Instruments Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on May 22, 2019 as substantially equivalent to K173246 (Wenzhou Bokang Instruments Co., Ltd., 2018) after a 44-day review. Its family tree reaches back 5 generations to 1979. 9 later devices descend from it.
- Decided
- May 22, 2019
- Review
- 44 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K790810 (1979). 9 ancestors in all. 9 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 4 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 3 generations backK012194 Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001
- 2 generations backK043286 Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005
- 1 generation backK173246 Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018
- This deviceK190902 RH non-Automated Blood Pressure Meter RH non-Automated Blood…Wenzhou Renhua Instruments Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK192500 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerHonsun (Nantong) Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK211084 Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeShanghai Caremate Medical Device Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK212416 WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated…Wenzhou Xikang Medical Instruments Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK240165 Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerWenzhou Longwan Medical Device Factory · 2024
- Descendant · 2 generations on · 0 of its ownK230859 Aneroid SphygmomanometerWenzhou Kangshun Medical Devices Co.,Ltd · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerHonsun (Nantong) Co., Ltd. · 2020 · cites it directly3descendants
- K211084Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeShanghai Caremate Medical Device Co., Ltd. · 2021 · 2 generations on2descendants
- K212416WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter…Wenzhou Xikang Medical Instruments Co., Ltd. · 2022 · cites it directly1descendant
- K240165Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerWenzhou Longwan Medical Device Factory · 2024 · 3 generations on0descendants
- K230859Aneroid SphygmomanometerWenzhou Kangshun Medical Devices Co.,Ltd · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −4 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −3 | K012194 | Blood Pressure Monitor (Sphygmomanometer), Model HT-110 | Nihon Seimitsu Sokki Co., Ltd. | 2001 | — |
| −2 | K043286 | Aneroid Sphygmomanometer, Model BK2002 | Wenzhou Bokang Instrument Co.,Ltd | 2005 | — |
| −1 | K173246 | Aneroid Sphygmomanometer | Wenzhou Bokang Instruments Co., Ltd. | 2018 | — |
| 0 (this device) | K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter… | Wenzhou Renhua Instruments Co., Ltd. | 2019 | — |
| +1 | K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Honsun (Nantong) Co., Ltd. | 2020 | — |
| +2 | K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | Shanghai Caremate Medical Device Co., Ltd. | 2021 | — |
| +1 | K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood… | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022 | — |
| +3 | K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K173246 | Aneroid SphygmomanometerSummary page 4…e: DXQ; LDE Device Class: Class 2 Panel: Cardiovascular PREDICATE DEVICE: ANEROID SPHYGMOMANOMETER (K173246) INDICATIONS FOR USE RH non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for t… | 2018 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | 2020 | 3 |
| K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter… | 2022 | 1 |
| K221857 | Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20… | 2022 | 0 |
| K203620 | Aneroid Sphygmomanometer | 2021 | 0 |
| K193259 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | 2020 | 0 |
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 40 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K192500 (Honsun (Nantong) Co., Ltd., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
RH non-Automated Blood Pressure Meter 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/K190902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190902: RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter 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/K190902
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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