510(k) · Cleared
ClearedFemostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch Model 11168, Femostop II Bilateral ADAPT0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radi Medical Systems AB · DXC Clamp, Vascular
Cleared on Sep 18, 1998 after an 88-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.
- Decided
- Sep 18, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 2 citing it directly.
- This deviceK982182 Femostop II Plus Disposable Set Model 11166, Femostop II Plus…Radi Medical Systems AB · 1998
- Descendant · cites it directly · 25 of its ownK983471 Femostop Compression Arch, Femostop Pump, Femostop Bilateral AdapterRadi Medical Systems AB · 1999
- Descendant · cites it directly · 23 of its ownK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- Descendant · 2 generations on · 17 of its ownK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- Descendant · 3 generations on · 16 of its ownK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- Descendant · 2 generations on · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K983471Femostop Compression Arch, Femostop Pump, Femostop Bilateral AdapterRadi Medical Systems AB · 1999 · cites it directly25descendants
- K024107Femostop Femoral Compression SystemRadi Medical Systems AB · 2002 · cites it directly23descendants
- K040730Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004 · 2 generations on17descendants
- K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005 · 3 generations on16descendants
- K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982182 | Femostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch… | Radi Medical Systems AB | 1998 | — |
| +1 | K983471 | Femostop Compression Arch, Femostop Pump, Femostop Bilateral Adapter | Radi Medical Systems AB | 1999 | — |
| +1 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| +2 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| +3 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| +2 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | FemoStop®II System with FemoStop®II Disposable Set, FemoStop®II Compression Arch… Named without a submission number |
What descends from it? (26)
See all 262 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, K983471 (Radi Medical Systems AB, 1999) has gone furthest, with 25 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.
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 FemoStop®II'S System is indicated in the compression of the femoral artery or vein after catheterization.
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/K982182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982182: Femostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch Model 11168, Femostop II Bilateral ADAPT0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982182
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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