510(k) · Cleared
ClearedAneroid Sphygmomanometer, Model BK2002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzhou Bokang Instrument Co.,Ltd · DXQ Blood Pressure Cuff
Cleared on Jan 13, 2005 as substantially equivalent to K012194 (Nihon Seimitsu Sokki Co., Ltd., 2001) after a 48-day review. Its family tree reaches back 3 generations to 1979. 13 later devices descend from it.
- Decided
- Jan 13, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K790810 (1979). 7 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 2 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 1 generation backK012194 Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001
- This deviceK043286 Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005
- Descendant · cites it directly · 10 of its ownK173246 Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018
- Descendant · 2 generations on · 9 of its ownK190902 RH non-Automated Blood Pressure Meter RH non-Automated Blood…Wenzhou Renhua Instruments Co., Ltd. · 2019
- Descendant · 3 generations on · 3 of its ownK192500 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerHonsun (Nantong) Co., Ltd. · 2020
- Descendant · 4 generations on · 2 of its ownK211084 Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeShanghai Caremate Medical Device Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK212416 WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated…Wenzhou Xikang Medical Instruments Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173246Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018 · cites it directly10descendants
- K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with…Wenzhou Renhua Instruments Co., Ltd. · 2019 · 2 generations on9descendants
- K192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerHonsun (Nantong) Co., Ltd. · 2020 · 3 generations on3descendants
- K211084Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeShanghai Caremate Medical Device Co., Ltd. · 2021 · 4 generations on2descendants
- K212416WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter…Wenzhou Xikang Medical Instruments Co., Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −2 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −1 | K012194 | Blood Pressure Monitor (Sphygmomanometer), Model HT-110 | Nihon Seimitsu Sokki Co., Ltd. | 2001 | — |
| 0 (this device) | K043286 | Aneroid Sphygmomanometer, Model BK2002 | Wenzhou Bokang Instrument Co.,Ltd | 2005 | — |
| +1 | 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 | — |
| +3 | K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Honsun (Nantong) Co., Ltd. | 2020 | — |
| +4 | K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | Shanghai Caremate Medical Device Co., Ltd. | 2021 | — |
| +3 | K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood… | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K012194 | Blood Pressure Monitor (Sphygmomanometer), Model HT-110Summary page 1…d Sphygmomanorneter BK2002 is substantially equivalcnt to Nihon Seimitsu Sokki Co.,Ltd's model [HT-I 10 which 5 10(K) number is K0 12194 1)evicc Description The device comproseS tubing attached to a soft ineastic sleeve with an integrated inflat… | 2001 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K173246 (Wenzhou Bokang Instruments Co., Ltd., 2018) has gone furthest, with 10 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.
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 device is intended to be used by medical professionals or in the
home for the measurement of systolic and diastolic pressure on adults. The
device is intended to be manually attached to a patient and manually
inflated along with a manual method for detecting Korotkoff sounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043286: Aneroid Sphygmomanometer, Model BK2002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043286
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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