510(k) · Cleared
ClearedRadial Artery Compression Tourniquets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Demax Medical Technology Co.,Ltd · DXC Clamp, Vascular
Cleared on Jan 4, 2023 after a 166-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 4, 2023
- Review
- 166 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK222182 Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd · 2023
- Descendant · cites it directly · 0 of its ownK232577 Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd · 2024
Most influential descendants
Showing 1 of 1 · See all- K232577Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K222182 | Radial Artery Compression Tourniquets | Beijing Demax Medical Technology Co.,Ltd | 2023 | — |
| +1 | K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232577 | Radial Compression Device | 2024 | 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, K232577 (Ningbo Dizegens Medical Science Co.,Ltd, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K222182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222182: Radial Artery Compression Tourniquets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222182
Report an extraction error
Are you the manufacturer?
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