510(k) · Cleared
ClearedArc Adjustable Radial Cuff Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tz Medical, Inc. · DXC Clamp, Vascular
Cleared on Jan 10, 2018 as substantially equivalent to K152525 (Terumo Medical Corporation, 2015) after a 54-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Jan 10, 2018
- Review
- 54 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070423 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK070423 TR BandTerumo Medical Corp. · 2007
- 1 generation backK152525 TR BAND Radial Compression DeviceTerumo Medical Corporation · 2015
- This deviceK173563 Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK252772 Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070423 | TR Band | Terumo Medical Corp. | 2007 | — |
| −1 | K152525 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2015 | — |
| 0 (this device) | K173563 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | 2018 | — |
| +1 | K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K152525 | TR BAND Radial Compression DeviceSummary page 4…Product 510K Number Terumo Medical: TR Band Radial Compression Device K152525 L.) Device Description: The TZ Medial ARC Adjustable Radial Cuff “ARC” compression device is used at the end of a… | 2015 |
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 |
|---|---|---|---|
| K252772 | Arc Adjustable Radial Cuff Compression Device | 2026 | 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252772 (Tz Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152525.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
When applied by a trained health care professional, the TZ Medical ARC™ device is indicated to assist in controlled compression hemostasis of the radial artery after a transradial procedure; the device is indicated to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of the radial artery (patent hemostasis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173563: Arc Adjustable Radial Cuff 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/K173563
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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