510(k) · Cleared
ClearedReusable Blood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Vistar Medical Supplies Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Oct 29, 2015 as substantially equivalent to K151290 (Xuzhou Maicuff Technology Co., Ltd., 2015) after a 59-day review. Its family tree reaches back 4 generations to 1979. 4 later devices descend from it.
- Decided
- Oct 29, 2015
- Review
- 59 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. 4 later devices descend from it, 2 citing it directly.
- 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 backK151290 Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffXuzhou Maicuff Technology Co., Ltd. · 2015
- This deviceK152468 Reusable Blood Pressure CuffShenzhen Vistar Medical Supplies Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK171889 Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK233276 Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK254287 Medline Reusable Blood Pressure CuffMedline Industries, LP · 2026
- Descendant · cites it directly · 0 of its ownK173044 Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffNingbo Albert Novosino Co., Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K171889Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2017 · cites it directly2descendants
- K233276Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2023 · 2 generations on1descendant
- K254287Medline Reusable Blood Pressure CuffMedline Industries, LP · 2026 · 3 generations on0descendants
- K173044Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffNingbo Albert Novosino Co., Ltd. · 2017 · cites it directly0descendants
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 | K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | 2015 | — |
| 0 (this device) | K152468 | Reusable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015 | — |
| +1 | K171889 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2017 | — |
| +2 | K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023 | — |
| +3 | K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | 2026 | — |
| +1 | K173044 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Ningbo Albert Novosino Co., Ltd. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffSummary page 6…Page 3 of 5 5. Identification of Predicate Device(s) Predicate Device K151290 Reusable/Reusable Blood Pressure Cuff Xuzhou Maicuff Technology Co., Ltd. 6. Non-Clinical Test Conclusion N… | 2015 |
What descends from it? (4)
2 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 36 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.
- Of its descendants, K171889 (Suzhou Minhua Medical Apparatus Supplies Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K151290.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 infant, pediatric and adult sizes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152468: Reusable Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152468
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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