510(k) Report

510(k) · Cleared

Cleared

Femostop

K915280510(k) TraditionalCleared Apr 22, 1992149-day reviewClass II21 CFR 870.4450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Radi Medical Systems AB · DXC Clamp, Vascular

Cleared on Apr 22, 1992 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided
Apr 22, 1992
Review
149 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
0

22 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2007: 3 descendants cleared2002: 1 descendant cleared2012: 2 descendants cleared2010: 3 descendants cleared2013: 4 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared2014: 3 descendants cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK915280 FemostopRadi Medical Systems AB · 1992
  2. Descendant · cites it directly · 13 of its ownK061075 Boomerang WireCardiva Medical, Inc. · 2006
  3. Descendant · 2 generations on · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
  4. Descendant · 3 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
  5. Descendant · 4 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
  6. Descendant · 5 generations on · 9 of its ownK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2002: 12006: 22007: 32009: 12010: 32011: 22012: 22013: 42014: 32015: 1
2002high 4 (2013) · low 0 (2003)2026

Most influential descendants

Showing 5 of 22 · See all
  • K061075Boomerang WireCardiva Medical, Inc. · 2006 · cites it directly13descendants
  • K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · 2 generations on12descendants
  • K100615Arstasis Access SystemArstasis, Inc. · 2010 · 3 generations on11descendants
  • K102728Arstasis Access SystemArstasis, Inc. · 2010 · 4 generations on10descendants
  • K103143Arstasis One Latchwire Access SystemArstasis, Inc. · 2011 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915280FemostopRadi Medical Systems AB1992—
+1K061075Boomerang WireCardiva Medical, Inc.2006—
+2K091006Itg Vascular Access System, Model 300Arstasis, Inc.20101
+3K100615Arstasis Access SystemArstasis, Inc.20101
+4K102728Arstasis Access SystemArstasis, Inc.20101
+5K103143Arstasis One Latchwire Access SystemArstasis, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200620
200730
200910
201030
201120
201220
201340
201430
201510
FIG. 1 — Lineage of K915280, 1992–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061075Boomerang WireCardiva Medical, Inc.200613
K051817Boomerang Closurewire Vascular Closure SystemCardiva Medical, Inc.20064
K012574Reprocessed Femoral Compression DeviceSterilmed, Inc.20021
K063871D-Stat Handle, Model 8500-053Vascular Solutions, Inc.20070

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, K061075 (Cardiva Medical, Inc., 2006) has gone furthest, with 13 descendants of its own.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXC

2in 2025

2007: 102008: 32009: 42010: 22011: 62012: 52013: 142014: 42015: 52016: 32017: 32018: 22019: 22020: 32021: 62022: 12023: 42024: 12025: 22026 (partial year): 4
2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007: 52 days median2008: 29 days median2009: 83 days median2011: 51 days median2012: 73 days median2013: 89 days median2014: 157 days median2015: 71 days median2016: 91 days median2017: 90 days median2020: 209 days median2021: 37 days median2023: 215 days median2026 (partial year): 125 days median
2007high 215 (2023) · low 29 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXC

2in 2023

2008: 22009: 22010: 12011: 32014: 12022: 12023: 2
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXC

442in 2025

2007: 2982008: 3022009: 5392010: 6002011: 6912012: 5482013: 9202014: 4942015: 3742016: 4942017: 4162018: 3912019: 3932020: 4042021: 3712022: 2732023: 6742024: 3752025: 442
2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710520298
20083292302
20094832539
20102—1600
20116513691
20125730548
201314890920
201441571494
20155710374
20163910494
20173900416
20182—0391
20192—0393
202032090404
20216370371
20221—1273
202342152674
20241—0375
20252—0442
202641250—

More from Radi Medical Systems AB

24 FDA decisions under this applicant name. See the company

  • K123984Quantien Measurement SystemRadi Medical Systems AB · 2013
  • K092105Radianalyzer XpressRadi Medical Systems AB · 2009
  • K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
  • K080206Modification to Femostop Femoral Compression SystemRadi Medical Systems AB · 2008
  • K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006

Recent decisions in DXC

The DXC category page

  • K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
  • K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences · 2026
  • K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026
  • K254060Life Saving TourniquetTW Medical · 2026
  • K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC · 2025

https://510kreport.com/device/K915280 · printed Nov 4, 2026

Cite this page

510(k) Report. “K915280: Femostop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915280

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026