510(k) · Cleared
ClearedAir-Band Radial Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp., Cardiac Assist Division · DXC Clamp, Vascular
Cleared on Nov 9, 2012 as substantially equivalent to K070423 (Terumo Medical Corp., 2007) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Nov 9, 2012
- Review
- 94 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K062569 (2007). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK062569 Safeguard 24 CM Pressure Assisted DressingDatascope Corp. · 2007
- This deviceK122405 Air-Band Radial Compression DeviceDatascope Corp., Cardiac Assist Division · 2012
- Descendant · cites it directly · 0 of its ownK132293 Syvek Radial BandMarine Polymer Technologies · 2014
- Descendant · cites it directly · 0 of its ownK131411 CosealJilin Coronado Medical, Ltd. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062569 | Safeguard 24 CM Pressure Assisted Dressing | Datascope Corp. | 2007 | — |
| 0 (this device) | K122405 | Air-Band Radial Compression Device | Datascope Corp., Cardiac Assist Division | 2012 | — |
| +1 | K132293 | Syvek Radial Band | Marine Polymer Technologies | 2014 | — |
| +1 | K131411 | Coseal | Jilin Coronado Medical, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070423 | TR BandSummary page 1…e: AlR-BAND Radial Compression Device Common/Usual Name: Compression Device Classification Name: 21 CFR 870.4450 Vascular Clamp Predicate Devices: K070423 TR Band TM K062569 Safeguard® 24cm Pressure Assisted Dressing Device Description: AIR-BAND TM is a s… | 2007 |
| * | K062569 | Safeguard 24 CM Pressure Assisted DressingSummary page 1…vice Common/Usual Name: Compression Device Classification Name: 21 CFR 870.4450 Vascular Clamp Predicate Devices: K070423 TR Band TM K062569 Safeguard® 24cm Pressure Assisted Dressing Device Description: AIR-BAND TM is a sterile, single use, 6-month shelf life, disp… | 2007 |
What descends from it? (2)
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?
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122405: Air-Band 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/K122405
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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