510(k) · Cleared
ClearedReusable NIBP Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Changke Connect Electronics Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Sep 17, 2019 as substantially equivalent to K182433 (Shenzhen Caremed Medical Technology Co., Ltd., 2018) after a 131-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Sep 17, 2019
- Review
- 131 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K790810 (1979). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 3 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 2 generations backK120364 Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012
- 1 generation backK182433 Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffShenzhen Caremed Medical Technology Co., Ltd. · 2018
- This deviceK191253 Reusable NIBP CuffShenzhen Changke Connect Electronics Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −3 | 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 | K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K191253 | Reusable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | 2019 | — |
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 |
| 2002 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffSummary page 4…s comparable to the following legally marketed system: 1. Shenzhen Caremed Medical Technology Co., Ltd. Reusable Blood Pressure Cuff under K182433. The subject device has same intended use, same target patient population, same performance effectiveness, per… | 2018 |
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 40 years and passes through 5 companies; a new generation was cleared every 14.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 5 other devices also cite its predicate K182433.
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?
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191253: Reusable NIBP Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191253
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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