510(k) · Cleared
ClearedTR BAND Radial Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corporation · DXC Clamp, Vascular
Cleared on Nov 10, 2015 as substantially equivalent to K070423 (Terumo Medical Corp., 2007) after a 68-day review. Its family tree reaches back 1 generation to 2007. 4 later devices descend from it.
- Decided
- Nov 10, 2015
- Review
- 68 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070423 (2007). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK070423 TR BandTerumo Medical Corp. · 2007
- This deviceK152525 TR BAND Radial Compression DeviceTerumo Medical Corporation · 2015
- Descendant · cites it directly · 1 of its ownK213531 TR BAND Radial Compression DeviceTerumo Medical Corporation · 2021
- Descendant · cites it directly · 1 of its ownK173563 Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK252772 Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253070 Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band…Medline Industries, LP · 2025
Most influential descendants
Showing 4 of 4 · See all- K213531TR BAND Radial Compression DeviceTerumo Medical Corporation · 2021 · cites it directly1descendant
- K173563Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2018 · cites it directly1descendant
- K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026 · 2 generations on0descendants
- K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070423 | TR Band | Terumo Medical Corp. | 2007 | — |
| 0 (this device) | K152525 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2015 | — |
| +1 | K213531 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2021 | — |
| +1 | K173563 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | 2018 | — |
| +2 | K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | 2026 | — |
| +2 | K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm… | Medline Industries, LP | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K070423 | TR BandSummary page 6…DXC Classification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed is: K070423 – TR BandTM, manufactured by Terumo Corporation, Japan D. DEVICE DESCRIPTION (807.92(a)(4)) The TR BAND® Radial Compression… | 2007 |
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?
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 TR BAND® Radial Compression Device 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/K152525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152525: TR BAND Radial Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152525
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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