510(k) · Cleared
ClearedSensa-Cuff, Models Infant, Child, Adult
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DXQ Blood Pressure Cuff
Cleared on Aug 13, 2002 after a 15-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- Aug 13, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 6 citing it directly.
- This deviceK022482 Sensa-Cuff, Models Infant, Child, AdultGe Medical Systems Information Technologies · 2002
- Descendant · cites it directly · 24 of its ownK112544 Unimed Blood Pressure CuffUnimed Medical Supplies, Inc. · 2011
- Descendant · 2 generations on · 9 of its ownK151290 Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffXuzhou Maicuff Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 7 of its ownK182433 Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffShenzhen Caremed Medical Technology Co., Ltd. · 2018
- Descendant · 3 generations on · 4 of its ownK152468 Reusable Blood Pressure CuffShenzhen Vistar Medical Supplies Co., Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK120125 Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-CufGe Medical Systems Information Technologies, Inc. · 2012
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K112544Unimed Blood Pressure CuffUnimed Medical Supplies, Inc. · 2011 · cites it directly24descendants
- K151290Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffXuzhou Maicuff Technology Co., Ltd. · 2015 · 2 generations on9descendants
- K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffShenzhen Caremed Medical Technology Co., Ltd. · 2018 · 2 generations on7descendants
- K152468Reusable Blood Pressure CuffShenzhen Vistar Medical Supplies Co., Ltd. · 2015 · 3 generations on4descendants
- K120125Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-CufGe Medical Systems Information Technologies, Inc. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022482 | Sensa-Cuff, Models Infant, Child, Adult | Ge Medical Systems Information Technologies | 2002 | — |
| +1 | K112544 | Unimed Blood Pressure Cuff | Unimed Medical Supplies, Inc. | 2011 | — |
| +2 | K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | 2015 | — |
| +2 | K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| +3 | K152468 | Reusable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015 | — |
| +1 | K120125 | Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf | Ge Medical Systems Information Technologies, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 13.4 · 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? (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 |
|---|---|---|---|
| * | — | DURA-CUFB-Preamendment Named without a submission number |
What descends from it? (35)
See all 356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112544 | Unimed Blood Pressure Cuff | 2011 | 24 |
| K120125 | Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf | 2012 | 3 |
| K070060 | Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood… | 2007 | 2 |
| K092999 | NBP Cuff | 2009 | 0 |
| K063863 | Advantage Cuff, Non-Invasive Blood Pressure Hose and Adapter | 2007 | 0 |
| K061962 | Surgi-Cuf Reusable, RS Series | 2006 | 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?
- Of its descendants, K112544 (Unimed Medical Supplies, Inc., 2011) has gone furthest, with 24 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 Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022482: Sensa-Cuff, Models Infant, Child, Adult.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022482
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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