510(k) · Cleared
ClearedRadial Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Dizegens Medical Science Co.,Ltd · DXC Clamp, Vascular
Cleared on Jan 18, 2024 as substantially equivalent to K222182 (Beijing Demax Medical Technology Co.,Ltd, 2023) after a 146-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Jan 18, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K222182 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backK222182 Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd · 2023
- This deviceK232577 Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K222182 | Radial Artery Compression Tourniquets | Beijing Demax Medical Technology Co.,Ltd | 2023 | — |
| 0 (this device) | K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | 2024 | — |
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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 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 |
|---|---|---|---|
| * | K222182 | Radial Artery Compression TourniquetsSummary page 5…gally marketed device(s) to which substantial equivalence is claimed is the Beijing Demax Medical Technology Co., Ltd. Radial Artery Compression Tourniquets (K222182). D. Device Description The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial ar… | 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?
- Its one ancestor has no recall.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232577: Radial Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232577
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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