510(k) · Cleared
ClearedModification to Femostop Femoral Compression System
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 Feb 26, 2008 as substantially equivalent to K024107 (Radi Medical Systems AB, 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 26, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953781 (1995). 13 ancestors in all, the oldest K920796 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 3 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 2 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 1 generation backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- This deviceK080206 Modification to Femostop Femoral Compression SystemRadi Medical Systems AB · 2008
- Descendant · cites it directly · 0 of its ownK192413 SiteSeal Femoral Compression DeviceEnsite Vacular, LLC · 2020
- Descendant · cites it directly · 0 of its ownK120204 Reprocessed Femoral Compression DeviceSterilmed, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK110193 Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II…St. Jude Medical Systems AB · 2011
Most influential descendants
Showing 3 of 3 · See all- K192413SiteSeal Femoral Compression DeviceEnsite Vacular, LLC · 2020 · cites it directly0descendants
- K120204Reprocessed Femoral Compression DeviceSterilmed, Inc. · 2012 · cites it directly0descendants
- K110193Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II…St. Jude Medical Systems AB · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −3 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −2 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −1 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| 0 (this device) | K080206 | Modification to Femostop Femoral Compression System | Radi Medical Systems AB | 2008 | — |
| +1 | K192413 | SiteSeal Femoral Compression Device | Ensite Vacular, LLC | 2020 | — |
| +1 | K120204 | Reprocessed Femoral Compression Device | Sterilmed, Inc. | 2012 | — |
| +1 | K110193 | Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set… | St. Jude Medical Systems AB | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024107 | Femostop Femoral Compression SystemSummary page 1…kstrand Date Prepared: January 23", 2008 Proprietary Name: FemoStop® Femorat Compression System Regulation Name: Vascular clamp Product code: DXC Predicate Devices: 024107 FemoStop® HD Femoral Compression System K062033 BP101 Digital Blood Pressure Monitor Description of the Device: This combinatio… | 2002 |
| * | K062033 | BP 101 Digital Blood Pressure MonitorSummary page 1…ietary Name: FemoStop® Femorat Compression System Regulation Name: Vascular clamp Product code: DXC Predicate Devices: 024107 FemoStop® HD Femoral Compression System K062033 BP101 Digital Blood Pressure Monitor Description of the Device: This combination of FemoStop@Femaral Compression System consists… | 2007 |
What descends from it? (3)
3 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K192413 (Ensite Vacular, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K024107.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm
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/K080206 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080206: Modification to Femostop Femoral Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080206
Report an extraction error
Are you the manufacturer?
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