510(k) · Cleared
ClearedStatcorp Inc. Disposable Blood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Statcorp, Inc. · DXQ Blood Pressure Cuff
Cleared on Feb 22, 1994 after a 39-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 52 later devices descend from it.
- Decided
- Feb 22, 1994
- Review
- 39 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 4 citing it directly.
- This deviceK940214 Statcorp Inc. Disposable Blood Pressure CuffStatcorp, Inc. · 1994
- Descendant · cites it directly · 51 of its ownK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 23 of its ownK120364 Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012
- Descendant · cites it directly · 14 of its ownK012194 Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001
- Descendant · 2 generations on · 13 of its ownK043286 Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005
- Descendant · 3 generations on · 10 of its ownK173246 Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K974080Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · cites it directly51descendants
- K120364Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012 · 2 generations on23descendants
- K012194Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001 · cites it directly14descendants
- K043286Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005 · 2 generations on13descendants
- K173246Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940214 | Statcorp Inc. Disposable Blood Pressure Cuff | Statcorp, Inc. | 1994 | — |
| +1 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| +2 | K120364 | Unimed Disposable Blood Pressure Cuff | Unimed Medical Supplies, Inc. | 2012 | — |
| +1 | 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 | — |
| +3 | K173246 | Aneroid Sphygmomanometer | Wenzhou Bokang Instruments Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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 13.4 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (52)
See all 524 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?
- Of its descendants, K974080 (Johnson & Johnson Medical, Inc., 1998) has gone furthest, with 51 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 | — |
https://510kreport.com/device/K940214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940214: Statcorp Inc. Disposable Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940214
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026