510(k) · Cleared
ClearedAViTA Arm Type Blood Pressure Monitor Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avita Corporation · DXQ Blood Pressure Cuff
Cleared on Sep 3, 2025 as substantially equivalent to K231961 (Shenzhen Sino-K Medical Technology Co.,Ltd, 2023) after a 174-day review. Its family tree reaches back 5 generations to 1979.
- Decided
- Sep 3, 2025
- Review
- 174 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K790810 (1979). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 4 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 3 generations backK120364 Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012
- 2 generations backK182433 Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffShenzhen Caremed Medical Technology Co., Ltd. · 2018
- 1 generation backK231961 NIBPCuffShenzhen Sino-K Medical Technology Co.,Ltd · 2023
- This deviceK250765 AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −4 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −3 | K120364 | Unimed Disposable Blood Pressure Cuff | Unimed Medical Supplies, Inc. | 2012 | — |
| −2 | K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| −1 | K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023 | — |
| 0 (this device) | K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | 2025 | — |
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 |
|---|---|---|---|
| * | K231961 | NIBPCuffSummary page 5…DXQ Regulation Number: 870.1120 Device Class: II 3 PREDICATE DEVICE 510(k) Number: K231961 Trade Name: Reusable NIBP Cuff Manufacturer: Shenzhen SINO-K Medical Te… | 2023 |
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 46 years and passes through 6 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 cuff is compatible with non-invasive blood pressure monitors to measure blood pressure.
It is intended for use by healthcare professionals (prescription use) and by laypersons in home settings
(over-the-counter use).
The cuff is designed for adult patients. It is non-sterile and reusable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250765: AViTA Arm Type Blood Pressure Monitor Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250765
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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