510(k) · Cleared
ClearedSafeguard 24 CM Pressure Assisted Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · DXC Clamp, Vascular
Cleared on Feb 14, 2007 after a 167-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Feb 14, 2007
- Review
- 167 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
4 later devices descend from it, 2 citing it directly.
- This deviceK062569 Safeguard 24 CM Pressure Assisted DressingDatascope Corp. · 2007
- Descendant · cites it directly · 2 of its ownK122405 Air-Band Radial Compression DeviceDatascope Corp., Cardiac Assist Division · 2012
- Descendant · cites it directly · 0 of its ownK191827 Sunmed Disposable Angio-Closure PadsSunny Medical Device (Shenzhen) Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK132293 Syvek Radial BandMarine Polymer Technologies · 2014
- Descendant · 2 generations on · 0 of its ownK131411 CosealJilin Coronado Medical, Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K122405Air-Band Radial Compression DeviceDatascope Corp., Cardiac Assist Division · 2012 · cites it directly2descendants
- K191827Sunmed Disposable Angio-Closure PadsSunny Medical Device (Shenzhen) Co., Ltd. · 2020 · cites it directly0descendants
- K132293Syvek Radial BandMarine Polymer Technologies · 2014 · 2 generations on0descendants
- K131411CosealJilin Coronado Medical, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062569 | Safeguard 24 CM Pressure Assisted Dressing | Datascope Corp. | 2007 | — |
| +1 | K122405 | Air-Band Radial Compression Device | Datascope Corp., Cardiac Assist Division | 2012 | — |
| +1 | K191827 | Sunmed Disposable Angio-Closure Pads | Sunny Medical Device (Shenzhen) Co., Ltd. | 2020 | — |
| +2 | K132293 | Syvek Radial Band | Marine Polymer Technologies | 2014 | — |
| +2 | K131411 | Coseal | Jilin Coronado Medical, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K033300 | FDA’s K033300 is Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| Kept off the family tree | K021182 | FDA’s K021182 is Radiolucent Colles Compression/Distraction Bar Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
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?
- Of its descendants, K122405 (Datascope Corp., Cardiac Assist Division, 2012) has gone furthest, with 2 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. 2007, 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 indications for use for the Safeguard 24 cm pressure assisted
device are to assist in obtaining and maintaining hemostasis. The
device is also indicated in the reduction of active compression time
in femoral artery cannulation following diagnostic and
interventional procedures with an ACT of 140 seconds or less,
using a 6 French and smaller sheath size.
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/K062569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062569: Safeguard 24 CM Pressure Assisted Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062569
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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